Author contributions
All authors participated in study design and conduct, in data acquisition, analysis and interpretation and in drafting and revising the manuscript; and all authors approved the final version before submission. C.B. performed statistical analyses. A.S. and E.M.C. verified the underlying data. S.J. verified the pharmacokinetic and immunogenicity data. M.A.D. verified the pharmacodynamic data. All authors had access to the study data and had final responsibility for the decision to submit the manuscript for publication. A medical writer assisted in manuscript preparation, with funding from the sponsor.