Authors’ contributions
DM, FM
IC, JRF, FR, LB, AB, VAB, AAO, GA, SA, RB, NBM, LC, FC, MC, AC, LC, BF, LF, JFC, SG, GG, RG, GL, MSL, SM, LM, FM, DM, FM, MTP, AP, FP, MPP, LRF, FMR, MS, AS, GV, and CD have made substantial contributions to the design of the study protocol.