Authors’ contributions {31b}
FM
GB conceived and designed the trial. FH, JR, FG, FB, CH, GAB, MW, PJ, KD, MV, DF, HN, MB, BB, KB, OV, PM, LR, JIR, SJLB, KE and DC participated in the trial design. FM provided preliminary data. HH and FK provided statistical expertise. AMP and DRA provided support concerning ethical, legal and social considerations. All authors read and approved the final manuscript.