Author contributions
D.F.
ADVERSE EVENTS
Conception or design of the work (G.G., E.M., L.M., C.S., S.C.S., S.W.); finalization of analysis plans (S.M., H.S., J.T.); the acquisition of the data (D.F., J.R.K., V.OK., S.KP., S.C.S., S.W.); the analysis of the data (S.M., H.S.); the interpretation of data (M.C., G.G., C.S., L.M., S.M., H.S., J.T.). All authors drafted the work, revised it critically for important intellectual content, reviewed and approved the manuscript before submission, and vouch for the adherence of the trial to the protocol, the completeness and accuracy of the data and analyses, and the reporting of adverse events. Authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy of integrity of any part of the work are appropriately investigated and resolved.