Authors’ contributions
JDCR was responsible for identifying the research question. JCDR, LJ, FG, TH and AAM contributed to the study design. JDCR, CB, JK, MD, FG, LJ, TH, AAM, and GD developed the protocol. JCDR, LAB, CB, AM, MO, TH, JD and AAM contributed to the co-ordination, management, and delivery of the trial. JAW and FG designed, analysed and reported the qualitative component of the trial. LR and ZA designed, analysed and reported the health economics component of the trial. MO and TH analysed the clinical component of the trial. JDCR, MO, TH, AAM, and JD interpreted the clinical results. JDCR, LAB and TH drafted and revised the manuscript. JDCR, LAB, CB, JK, MD, JAW, MO, LJ, ZA, TH, FG, AAM, JD, AM and GD all critically appraised and approved the manuscript.