Authors’ contributions
JM: Co-primary investigator, drafted the original protocol, responsible for the conduct of the trial and data collection, drafted this manuscript. CH: Study concept and design, participated in the conduct of the trial. LR: Participated in the conduct of the trial and data collection. LO, FF, LA, NV, LB: Co-investigators, co-drafted the original protocol, participated in the conduct of the trial. TE: Co-principal investigator and sponsor, co-drafted the original protocol, is overall responsible for the initiation and conduct of the trial. JL: Principal investigator, co-drafted the original protocol, is overall responsible for the initiation and conduct of the trial. All authors read and approved the final manuscript.