Author contributions
T.A.Y., E.F., E.K.L., D.R.S., M.H., S.L., N.B.M., B.A.C., L.C., R.P., F.M.B. and E.R. contributed to data acquisition. J.O. contributed to safety data review and analysis. T.A.Y., G.M.C., J.S.R.F., E.R., J.D.S., M.W., A.F., P.M., Y.X., I.M.S., D.U., V.R. and M.K. contributed to study design, interpretation and/or data analysis. V.R., M.K., M.Z. and T.A.Y contributed to study conceptualization and design. All authors contributed to the development of the manuscript and reviewed the final version.