Authors’ contributions {31b}
RS
RV is the principal investigator; she conceived the study and led the proposal and protocol development. CG, AC, ACo, CC, AM, RS, FL, GC, GM, SS, SN, SMM, and PN are lead investigators; they contributed to the study design and to the development of the proposal. NDV and ER are research physicians; they contributed to the study design and to the development of the proposal. ADM is a research nurse; he contributed to the study design and to the development of the proposal. LS was the lead trial methodologist. All authors have read and approved the final manuscript.