Outcomes for participants will be analysed in the groups to which they are assigned regardless of deviation from the protocol or treatment received (intention-to-treat). Comparative statistical analysis will entail calculating the relative risk (RR) (95% CI) for the primary outcome (99% CIs for all dichotomous secondary outcomes), the mean difference (99% CI) for normally distributed continuous secondary outcomes, or the median difference (99% CI) for skewed continuous variables.