Author contributions
N.N.A., M.C.B. and S.Z. contributed to the study design. T.A.W., A.M.C., S.M., G.S. and B.H. conducted the trial and collected data. J.C. and S.Z. were responsible for statistical analyses. S.Z., J.C., N.N.A., M.C.B. and T.F. are the guarantors of this work and, as such, take responsibility for the integrity of the data and the accuracy of data analysis. All authors participated in data interpretation, manuscript writing (assisted by a medical writer paid for by the funder) and critical review of the manuscript, had full access to all the data in the study and approved the submission of this manuscript for publication.