Authors’ contributions
V.K., H.M.S, S.K., R.K., C.C.S. and E.F. conceived and designed the trial. A.R. designed the randomization procedure and generated the randomization lists. V.K., H.M.S. and S.K. conceptualized the manuscript. V.K. and H.M.S. wrote the paper and R.K., S.K., A.R., C.C.S., E.F. revised it critically. All authors have read and approved the final version of the manuscript.