Secondary outcomes
Secondary outcomes for the PwD and CG will be analysed similarly to the primary outcome at 90 days and 180 days (where applicable) post-randomisation. The treatment effect will be obtained unadjusted as the mean difference from baseline to post-randomisation between the groups MI plus SC versus SC alone and MI plus SC versus RI plus SC. Appropriate transformations may be applied to the variables before fitting the model if considered skewed.