Authors’ contributions
Authors E.J., R.A.K., and E-M.L. designed the study and wrote the protocol. Authors S.K.R. and M.R. were local principal investigators, I.J. was local study manager, Authors E.J., R.A.K., S.K.R, and M.R. collected data. Authors L.S. and R.G. undertook the statistical analysis, and authors L.S., R.G., P.M.J., A.B. and E.J. wrote the first draft of the manuscript. In addition, all authors critically read the manuscript and contributed academically to the data interpretations and writing. All authors approved the final version of the manuscript before submission.