Subgroup analyses
We will perform subgroup analyses on the primary outcomes, only if the primary analysis of that outcome indicates that the intervention was successful (i.e., in the case of the composite safety outcome, if the intervention is found to be non-inferior). Subgroups will be based on pre-specified baseline characteristics (Table In each sub-group analysis, we will investigate how the treatment effect varies between subgroups by adding the grouping variable as a covariate in the main analysis model, both with and without a treatment-arm interaction term. The models with and without the interaction will be compared using a likelihood-ratio test (LRT). We will report the LRT Additional subgroup analyses are specified in two embedded sub-studies (“Sub-studies” section).