Author contributions
SECONDARY
J.M.t.M. and K.D. wrote the study protocol. All others approved the study protocol. D.P. did the statistical analysis for the dual primary endpoint. J.M.t.M. and K.D. planned and did the secondary, safety and exploratory analyses. J.M.t.M. wrote the first draft of the paper with input from K.D. All other authors provided substantial contribution to the acquisition of data and revision of the manuscript. J.M.t.M., I.E.B. and K.D. accessed and verified the underlying study data. All authors had full access to all the data in the study, and J.M.t.M. had final responsibility for the decision to submit for publication. All authors have seen and approved the paper before submission, and agreed on the decision to submit the paper.