Authors’ contributions
RECRUITMENT
A.N. wrote most of the manuscript, H.F. performed statistical analyses and prepared figures and tables in close collaboration with O.S., B.N. and A.W. planned the clinical trial with B.N. serving as PI. J.R. kept the database, T.F., T.H., H.L., NO.B. and P.M. were responsible for patient recruitment at their trial centers and L.R. coordinated discussions regarding data management and endpoints. All authors reviewed the manuscript.