Authors’ contributions
LKI prepared the manuscript and is the medical trial coordinator. ES is the principal investigator. GI is the deputy principal investigator. ES, LKI, RU, AF, EL, EB, TD, FS, AO, NM, IS, AV, EV, JW, SN, HF, AR, CG, DH, SB, JWe, DG, MB, SW, GIh, JF, and GI participated in preparing the manuscript and study protocol. SW will conduct the statistical analysis for the trial. All authors have read and approved the final manuscript.