Author contributions
RECRUITMENT
C.J.M. was the lead investigator and performed data collection, data interpretation, participant recruitment and writing/critical review of the manuscript. A.B.-H., D.J.B., E.G.B.V., P.P.D., S.D., M.J., A.S., J.O.R., A.C.L. and B.R. performed data collection, data interpretation, participant recruitment and critical review of the manuscript. H.K., E.E.S. and B.F. carried out data analysis and interpretation and critical review of the manuscript. L.M. oversaw study design, data collection, data interpretation and participant recruitment and performed critical review of the manuscript. K.M.M. performed data collection, data interpretation, data analysis and writing of the manuscript. C.Y. performed clinical operations and critical review of the manuscript. T.B. was responsible for regulatory oversight and performed data interpretation and critical review of the manuscript. D.L. performed statistical analysis plan design, data collection, data analysis and data interpretation. D.A.N. performed data analysis, data interpretation and writing and critical review of the manuscript. R.C. performed data analysis/interpretation and critical review of the manuscript. D.L.G., E.H. and E.R. performed data analysis/interpretation and critical review of the manuscript. C.F.B. performed data interpretation and critical review of the manuscript. C.J. oversaw study design, data collection, data analysis, data interpretation and writing of the manuscript. R.M.L. was responsible for study design and data interpretation and performed writing and critical review of the manuscript.