Author contributions
I.K.M., T.F.C., P.Y.W., I.A-R., E.A.M., K.B.P., B.M.E., K.L., J.L.C., L.S. and S.S.P. designed the study. B.M.E., T.F.C. and I.K.M. provided methodology. I.K.M., P.Y.W., J.W.T., E.A.M., I.A-R., K.B.P., B.M.E., M.K.R., S. Chun, J.L.C., T.F.C., M.L., K.L., A.T., S. Choe, Y.T., S.S., S.S.P., I.H. and L.S. acquired, analyzed and interpreted data. Y.T. performed statistical analysis. S.S.P. supervised. I.K.M., M.L. and L.S. drafted the manuscript. The authors designed the trial and conducted data collection and analysis, in collaboration with the sponsor. The co-first authors wrote the first draft of the manuscript with input from all authors and medical writing support from the sponsor. All authors revised the manuscript and approved the submitted version.