Author contributions
AD
JPB, JT, XM, SXL, JB, SJH conducted generated and analyzed data. AD performed statistical analysis. MS, JT, NC, EMS, ans OA-W wrote the clinical trial protocol and conceived the study. JT, NC, JW, and EMS treated patients on trial. JT, EMS, and OAW oversaw the analyses and obtained funding. JPB and OA-W wrote the initial draft of the manuscript. All authors reviewed the manuscript and contributed to subsequent versions of the manuscript.