Authors’ contributions
JSP
GSC is the Chief Investigator. GSC, and JSP conceived study idea, designed, orchestrated multi-center trial, and organized funding. MKK, SYP, JGK, BWK, and SJB contributed to the trial design, and protocol development. JSP and HK planned and performed statistical analyses. MKK and SYP drafted this protocol manuscript and contributed equally to this study. JSP, SYP, JHB, SHC, ANS, HJK, DWK, JYK, EJP, GWH, JK, JHK, CHK, IJP participated in coordination and execution of the study. All authors provided input into the manuscript. All authors have read and approved the final version of the manuscript for publication.