Author contributions
A.V.D.
Y.P.M., K.C.G., J.M.M., J.R.P., S.G.G., A.M., K.M., K.K., E.R.B., G.P. and J.C. contributed to study concept and design. Y.P.M., K.C.G., A.M., J.R.P., J.M.M., L.M., L.C., M.G., A.V.D., R.M., D.A.M., S.S., M.E.M., N.P., G.S. and K.V. provided study materials or patients. S.G. and A.M. provided administrative support. A.M. was the medical monitor of the study. Y.P.M., K.C.G., Y.-Y.C., J.M., A.M., S.G.G., J.R.P., J.M.M., B.P., H.S., L.M.L., P.T.A., F.G., L.S., L.M., L.C., M.G., A.V.D., R.M., D.A.M., S.S., M.E.M., N.P., G.S., K.V., J.G.V., J.C. and M.L. contributed to data collection and assembly. Y.-Y.C. led the generation of data analyses. All authors were involved in data interpretation and in the writing, revision and critical review of the manuscript. All authors have approved the submitted version and are accountable for their contributions and the integrity of the work.