Authors’ contributions
DM, MM
CL, PR, ESL, and ME drafted the manuscript. JR, XA JBB, EBM, MB, CB, DB, EC, FJCO, JADM, CD, RF, FGH, JBG, DJ, JLL, MM, IM, MM, DM, DM, JM, MN, FPR, EP, VP, JRM, MR, ES, VS, ASB, ES, CSM, GT, JT, and AVF provided a critical review, and, as investigators at each institution, will promote enrolment of patients. CL registered the study. CTC contributed to the statistical analysis. CL and ESL designed and created the eCRF. ME, FFB, and VM participated in the design of the study and provided a critical review. CL and ME conceived the project and designed the study. All authors read and approved the final manuscript.