Multiple testing
SECONDARY
There are a total of three treatment comparisons: (1) MI plus SC vs SC only (2) RI plus SC vs SC only and (3) MI plus SC vs RI plus SC. The comparison of MI plus SC vs SC only and RI plus SC vs SC only will occur at the 5% level of significance. The comparison of MI plus SC vs SC only is the primary comparison. A hierarchical fixed sequence testing procedure will allow for comparison of the primary outcome (NPI-Q severity total score) between MI and RI at 90 days at the 5% significance level if there is strong evidence (Secondary outcomes were not powered for. Therefore, no multiplicity adjustment for the analysis of the secondary outcomes will be adopted. Instead, all effect sizes, CIs and 