Author contributions
All authors collected and analysed the data and provided critical review of the manuscript. J.A.K., P.M., N.M.T., and C.G.W. designed the clinical study, monitored, and interpreted clinical data. J.A.K., P.M., S.F.M., M.T.C., A.J.Z., A.Y.S., I.I.W., L.M.S.S., C.L.F., M.L., A.A., N.M.T., and C.G.W. enrolled patients on the study. X.Y. contributed to the statistical analysis. C.L.H. and P.O. contributed to the translational biomarker plan design, execution, analysis, and interpretation. E.M., D.D., E.R.P., and C.D.C. contributed to the biomarker data analysis and interpretation. Development of the first draft of the manuscript was led by the lead authors. All authors contributed to drafting the manuscript and provided final approval. J.A.K. and P.M. had final responsibility for the decision to submit for publication. J.A.K. and P.M. contributed equally to the manuscript and share lead authorship.