Author contributions
Authors AJG, AJOW, IBH, and SGG were involved in the conception and the design of the study, authors AJG, AJOW, YJS, SGG, and IBH were involved in the development of the initial protocol and ethics submission, authors AJG, AJOW YJS, RT, IP, JG, MMD, ZA, JW, EET, and IBH collected trial data, authors AJG and KAB analysed and reviewed final trial data with the independent statistician and wrote the first draft of the manuscript. All authors provided edit and review of the manuscript and approved submission of the final manuscript.