Authors’ contributions
MH, CM
MJH is the Chief Investigator of the trial. MJH, CWCL, JL, DM, AT, CM and OC conceived the trial. MJH, CWCL, JL, DM, AT, CM and OC obtained trial funding. NCP, MJH, CWCL, JL, DM, AT, CM and OC contributed to the design of the trial. NCP, PLG, CWCL, JvD and MJH oversaw the design of the statistical analyses. NCP, PLG, CWCL, SDF, JvD and MJH were involved in the analysis planning. PLG is the senior statistician responsible for clinical effectiveness analyses. JvD is the senior health economist responsible for cost-effectiveness analyses. NCP drafted the manuscript. NCP, PLG, CWCL, SDF, JL, DM, AT, CGM, JvD, OC and MH contributed to the manuscript and approved the final version for publication.