Author contributions
MP, HT, FM
SPS was the chief investigator who conceived the original study design and obtained funding, together with AM, GdG, PS, JM, FM, DPO, ST, US, TF, CS, MP, DW, FV and GD. HT was the study coordinator who prepared the first draft and subsequent versions of this manuscript with JW and is joint first author with SPS. JW was the senior trial statistician who oversaw the team undertaking the statistical analyses. GB and PW undertook the statistical analysis and prepared tables and figures. JM designed the health economic component and AC undertook the health economics analysis and wrote corresponding sections under his direction. All authors critically reviewed the protocol and the manuscript and gave approval for the publication.