Author contributions
MTH
MTH, JR, RBD Jr, BMG, and KSH conceived and designed the study; RBD Jr, BMG, and PS were clinical trial lead researchers of this study; AR, JaE, JeE, RG, and MTH led trial operations for the study; RG served as safety monitor of the study; JR, RBDIII, RBD Jr, BMG and PS led data acquisition; all authors substantially participated in analysis and interpretation of data with SL and MTH leading the statistical analysis. KSH and MTH drafted the work and all authors participated in revising and editing. All authors read and approved the final manuscript.