Tags

Type your tag names separated by a space and hit enter

A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19.
N Engl J Med. 2021 03 11; 384(10):905-914.NEJM

Abstract

BACKGROUND

LY-CoV555, a neutralizing monoclonal antibody, has been associated with a decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients with coronavirus disease 2019 (Covid-19). Data are needed on the effect of this antibody in patients who are hospitalized with Covid-19.

METHODS

In this platform trial of therapeutic agents, we randomly assigned hospitalized patients who had Covid-19 without end-organ failure in a 1:1 ratio to receive either LY-CoV555 or matching placebo. In addition, all the patients received high-quality supportive care as background therapy, including the antiviral drug remdesivir and, when indicated, supplemental oxygen and glucocorticoids. LY-CoV555 (at a dose of 7000 mg) or placebo was administered as a single intravenous infusion over a 1-hour period. The primary outcome was a sustained recovery during a 90-day period, as assessed in a time-to-event analysis. An interim futility assessment was performed on the basis of a seven-category ordinal scale for pulmonary function on day 5.

RESULTS

On October 26, 2020, the data and safety monitoring board recommended stopping enrollment for futility after 314 patients (163 in the LY-CoV555 group and 151 in the placebo group) had undergone randomization and infusion. The median interval since the onset of symptoms was 7 days (interquartile range, 5 to 9). At day 5, a total of 81 patients (50%) in the LY-CoV555 group and 81 (54%) in the placebo group were in one of the two most favorable categories of the pulmonary outcome. Across the seven categories, the odds ratio of being in a more favorable category in the LY-CoV555 group than in the placebo group was 0.85 (95% confidence interval [CI], 0.56 to 1.29; P = 0.45). The percentage of patients with the primary safety outcome (a composite of death, serious adverse events, or clinical grade 3 or 4 adverse events through day 5) was similar in the LY-CoV555 group and the placebo group (19% and 14%, respectively; odds ratio, 1.56; 95% CI, 0.78 to 3.10; P = 0.20). The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47).

CONCLUSIONS

Monoclonal antibody LY-CoV555, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had Covid-19 without end-organ failure. (Funded by Operation Warp Speed and others; TICO ClinicalTrials.gov number, NCT04501978.).

Authors+Show Affiliations

No affiliation info availableFrom the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

33356051

Citation

ACTIV-3/TICO LY-CoV555 Study Group, et al. "A Neutralizing Monoclonal Antibody for Hospitalized Patients With Covid-19." The New England Journal of Medicine, vol. 384, no. 10, 2021, pp. 905-914.
ACTIV-3/TICO LY-CoV555 Study Group, Lundgren JD, Grund B, et al. A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. N Engl J Med. 2021;384(10):905-914.
Lundgren, J. D., Grund, B., Barkauskas, C. E., Holland, T. L., Gottlieb, R. L., Sandkovsky, U., Brown, S. M., Knowlton, K. U., Self, W. H., Files, D. C., Jain, M. K., Benfield, T., Bowdish, M. E., Leshnower, B. G., Baker, J. V., Jensen, J. U., Gardner, E. M., Ginde, A. A., Harris, E. S., ... Neaton, J. D. (2021). A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. The New England Journal of Medicine, 384(10), 905-914. https://doi.org/10.1056/NEJMoa2033130
ACTIV-3/TICO LY-CoV555 Study Group, et al. A Neutralizing Monoclonal Antibody for Hospitalized Patients With Covid-19. N Engl J Med. 2021 03 11;384(10):905-914. PubMed PMID: 33356051.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. AU - ,, AU - Lundgren,Jens D, AU - Grund,Birgit, AU - Barkauskas,Christina E, AU - Holland,Thomas L, AU - Gottlieb,Robert L, AU - Sandkovsky,Uriel, AU - Brown,Samuel M, AU - Knowlton,Kirk U, AU - Self,Wesley H, AU - Files,D Clark, AU - Jain,Mamta K, AU - Benfield,Thomas, AU - Bowdish,Michael E, AU - Leshnower,Bradley G, AU - Baker,Jason V, AU - Jensen,Jens-Ulrik, AU - Gardner,Edward M, AU - Ginde,Adit A, AU - Harris,Estelle S, AU - Johansen,Isik S, AU - Markowitz,Norman, AU - Matthay,Michael A, AU - Østergaard,Lars, AU - Chang,Christina C, AU - Davey,Victoria J, AU - Goodman,Anna, AU - Higgs,Elizabeth S, AU - Murray,Daniel D, AU - Murray,Thomas A, AU - Paredes,Roger, AU - Parmar,Mahesh K B, AU - Phillips,Andrew N, AU - Reilly,Cavan, AU - Sharma,Shweta, AU - Dewar,Robin L, AU - Teitelbaum,Marc, AU - Wentworth,Deborah, AU - Cao,Huyen, AU - Klekotka,Paul, AU - Babiker,Abdel G, AU - Gelijns,Annetine C, AU - Kan,Virginia L, AU - Polizzotto,Mark N, AU - Thompson,B Taylor, AU - Lane,H Clifford, AU - Neaton,James D, Y1 - 2020/12/22/ PY - 2020/12/29/pubmed PY - 2021/3/24/medline PY - 2020/12/28/entrez SP - 905 EP - 914 JF - The New England journal of medicine JO - N Engl J Med VL - 384 IS - 10 N2 - BACKGROUND: LY-CoV555, a neutralizing monoclonal antibody, has been associated with a decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients with coronavirus disease 2019 (Covid-19). Data are needed on the effect of this antibody in patients who are hospitalized with Covid-19. METHODS: In this platform trial of therapeutic agents, we randomly assigned hospitalized patients who had Covid-19 without end-organ failure in a 1:1 ratio to receive either LY-CoV555 or matching placebo. In addition, all the patients received high-quality supportive care as background therapy, including the antiviral drug remdesivir and, when indicated, supplemental oxygen and glucocorticoids. LY-CoV555 (at a dose of 7000 mg) or placebo was administered as a single intravenous infusion over a 1-hour period. The primary outcome was a sustained recovery during a 90-day period, as assessed in a time-to-event analysis. An interim futility assessment was performed on the basis of a seven-category ordinal scale for pulmonary function on day 5. RESULTS: On October 26, 2020, the data and safety monitoring board recommended stopping enrollment for futility after 314 patients (163 in the LY-CoV555 group and 151 in the placebo group) had undergone randomization and infusion. The median interval since the onset of symptoms was 7 days (interquartile range, 5 to 9). At day 5, a total of 81 patients (50%) in the LY-CoV555 group and 81 (54%) in the placebo group were in one of the two most favorable categories of the pulmonary outcome. Across the seven categories, the odds ratio of being in a more favorable category in the LY-CoV555 group than in the placebo group was 0.85 (95% confidence interval [CI], 0.56 to 1.29; P = 0.45). The percentage of patients with the primary safety outcome (a composite of death, serious adverse events, or clinical grade 3 or 4 adverse events through day 5) was similar in the LY-CoV555 group and the placebo group (19% and 14%, respectively; odds ratio, 1.56; 95% CI, 0.78 to 3.10; P = 0.20). The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47). CONCLUSIONS: Monoclonal antibody LY-CoV555, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had Covid-19 without end-organ failure. (Funded by Operation Warp Speed and others; TICO ClinicalTrials.gov number, NCT04501978.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/33356051/full_citation L2 - https://www.nejm.org/doi/10.1056/NEJMoa2033130?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -