Author contributions
The list of KEN SHE Team members at the end of the paper is in alphabetical order for each institution. R.V.B., D.D., E.R.B., N.R.M. and J.M.B. designed the trial. K.B.H. and T.T.S. performed the data analyses. M.A.O., R.V.B. and N.R.M. oversaw the study operations. All authors (R.V.B., E.R.B., M.A.O., E.A.B., B.N., R.L.W., D.A.G., L.F.P., D.D., I.W., C.B., S.K., K.B.H., D.G.K., D.P., S.M., E.R., S.C., T.T.S., R.S.M., C.C., J.M.B. and N.R.M.) contributed equally to the interpretation of results. R.V.B. wrote the first draft of the manuscript. All authors contributed equally to the execution of the trial and critically reviewed and approved the finalized manuscript.