Statistical analyses
SECONDARY, RECRUITMENT
Reasons for screen failures are summarised in the CONSORT flowchart, according to the 2010 Statement extension to pilot and feasibility studies [Primary outcome measures are presented with 95% CI for the following measures, at 48 and 96 weeks: participant retention, the proportion of individuals for whom data are missing, the proportion of individuals with ARs and the level of self-reported adherence to MVC. The latter was calculated by (a) the proportion of study medication dispensed that was returned at the final study visit (b) the mean number of doses taken that were prescribed. The proportion of eligible individuals approached who were successfully recruited with 95% CI, and the monthly recruitment rate, are also presented.For each secondary outcome, we estimated the difference in means between groups from baseline to 48 and to 96 weeks and the 95% CI around these differences [