Ethics approval and consent to participate
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The protocol was approved by the institutional review boards or independent ethics committees of all participating institutions. The study was approved by the following institutional review boards or independent ethics committees: Asan Medical Center Institutional Review Board 88; CEIm Hospital Universitario Ramon y Cajal Secretria del Comité; Chesapeake Institutional Review Board; Chonnam National University Hwasun Hospital Institutional Review Board; Dignity Health Bay Area Regional Institutional Review Board; Henry Ford Health System Research Administration; Korea University Guro Hospital Institutional Review Board; London-Surrey Borders Research Ethics Committee; Nebraska Methodist Hospital Institutional Review Board; Norwalk Hospital Institutional Review Board; Penn State Milton S. Hershey Medical Center, Penn State College of Medicine Human Subjects Protection Office; Samsung Medical Center Institutional Review Board 81; Severance Hospital Yonsei University Health System 50–1 Institutional Review Board; Seoul National University Bundang Hospital Institutional Review Board 82; Seoul National University Hospital Institutional Review Board 101; The Catholic University of Korea Seoul St. Mary’s Hospital Institutional Review Board 222; Tufts Medical Center/Tufts University Health Sciences Institutional Review Board; University of Kansas Medical Center Institutional Review Board; University of Pennsylvania Office of Regulatory Affairs; University of Southern California Health Sciences Institutional Review Board; University of Texas Medical Branch Institutional Review Board; Vanderbilt University Institutional Review Board, Wake Forest University Health Sciences Institutional Review Board; and Western Institutional Review Board. All patients were required to confirm their willingness to participate in this study as approved by the institutional review boards or independent ethics committees at each participating study site before any study-specific screening procedures were performed. All patients provided written informed consent for participation in this study as approved by the Institutional Review Board/Research Ethics Board/Independent Ethics Committee before any study-specific screening procedures were performed.Patients were also required to grant permission to use protected health information per the Health Insurance Portability and Accountability Act. In addition, patients were required to consent to and sign all approved amendments per the site institutional review board or independent ethics committee guidelines during the course of the study.The study was conducted in accordance with the Declaration of Helsinki and International Conference on Harmonisation Guidelines for Good Clinical Practice.