Duke University, Clinical Trials Transformation Initiative, Government of the United States of America - Center for Drug Evaluation and Research, Duke University - Duke Clinical Research Institute, Duke University - Duke Clinical Research Institute, University of Groningen - University Medical Center Groningen, Amphia Hospital, Bellvitge University Hospital, University of Córdoba, Henry Ford Health System, affiliation not provided to SSRN, Beaumont Health System, East Carolina University, Government of the United States of America - Center for Drug Evaluation and Research, Government of the United States of America - Center for Drug Evaluation and Research, Government of the United States of America - Center for Drug Evaluation and Research, Clinical Trials Transformation Initiative, Duke University - Division of Infectious Diseases, Duke University, Utrecht University - Julius Center for Health Sciences and Primary Care and University Medical Center Utrecht