Author contributions
N.E., M.G., U.S.S., J.G.D. and B.H.B. designed the trial. B.V. and A.G.H. amended the trial design based on input from J.T., among others. P.D., S.H.H. and D.L.B. served on the data monitoring committee. A.G.H. and B.V. monitored the trial for the sponsor while in the conduct phase. A.G.H. performed the supplementary statistical analyses. A.G.H. wrote the first draft of the paper and all authors revised it. All authors vouch for the accuracy and completeness of the reported data.