Contributors
MH, MPS, MHE, FM
MT, MF, and AB conceptualised and designed the study. IB, VB, IBo, LC, PC, OC, VC, DC, BD, TD, MHE, MCBVF, RG, SG, SH, MH, OK, HL, PL, FM, SN, MQ, AS, and MCZ recruited patients. AB, MF, HRH, DK, MK, RL, ML, PP, SP, GR, and MT collected and verified data. PP was project administrator. FBo, PB, PBr, and MPS did the statistical analyses. WA, EB, PB, AB, JB, FB, FBo, PBr, MF, AL, MPS, and MT supervised the study and interpreted the data. MT, MF, and AB prepared the first draft of the manuscript. Thereafter, the first draft was critically reviewed and revised by all authors. All authors had full access to all the data in the study and all had final responsibility for the decision to submit for publication. The authors vouch for the accuracy and completeness of the data and for the adherence of the trial to the protocol.