Author contributions
G.F.W., C.S., R.S., P.A.G., D.S., J.B. and P.C. enrolled participants in the clinical study and supervised the clinical components of the trial. G.F.W. additionally interpreted results and was involved in drafting and revision of the manuscript. J.H., B.G. and J.S.M. were involved in the oversight of the clinical study (including study design, protocol amendments and safety monitoring), study data analysis, interpreting results and revising the manuscript. S.M. and T.S. were involved in the data analysis, interpreting results and drafting and reviewing the manuscript. R.Z. performed statistical analysis of the study, interpreted results and critically revised the manuscript. D.G., I.J.G., J.W.K., R.A.H. and C.M.B. were involved in study design, interpreting results and revising the manuscript.