Authors’ contributions
The authors thank the participants and the staff at all study sites. CG is the National Institute for Health Research (NIHR) Clinical Doctoral Fellow and Chief Investigator. CG and FG developed the initial idea for the study. FG, WH, FP, JW, ES and KD made substantial contributions to the conception and design of the study. CG led the study, data analysis and interpretation. CG drafted the manuscript. All authors critically reviewed and revised the manuscript for important intellectual content. ES provided clinical trial operations and quality assurance expertise, LS provided statistical expertise, and GB provided health economics expertise. All authors read, amended, and approved the final manuscript.