Author contributions
FRT, SB-G, and FA conceived and designed the trial and FRT is the chief investigator. FFa, FFi, FHo, MAb, FHa, MV, FT, DK, MS-D, MB, AO, MAm, and FA contributed to the protocol and design of the study. RB-Y, MR, DK, and MS-D did the statistical analysis. FRT, SB-G, FHo, FFi, FFa and MR contributed to the preparation of the report. All authors contributed to the implementation of the study and data collection. All authors contributed to the article and approved the submitted version.