Authors’ contributions
RM and EH conceived the study. RM, EH, SM, CA, AC and MJ participated in its design and coordination, and RM, EH, SM, CA, AC, HE, YJ, SW, LG, PL, ML and DL helped draft the manuscript. KH, CMG, SW, YJ, HE, IH, ND, GS, and SK participated in the design of the study. YJ conducted the main analysis, LG, PL, and ML conducted the economic analysis. All authors read and approved the final manuscript. The Trial Steering Committee conceptualized and design the study: RM, EH, SM, HE, YJ, SW, DL, KH, CMG, IH, ND, GS, and SK. The author(s) read and approved the final manuscript.