Table 1 Summary of the analysis plan
Variables | Intention-to-treat cohort | Per-protocol cohort |
|---|---|---|
Baseline characteristics | No statistical comparisons | None |
Intervention and co-interventions | Chi-square, Fisher’s exact test, Wilcoxon–Mann–Whitney test, t-test as applicable | None |
Primary outcome | 1. Primary analysis: chi-square or Fisher’s exact test. Report relative risk. 2. Secondary analyses: unadjusted Cox proportional analysis, KM curves, adjusted logistic regression | 1. Primary analysis: chi-square or Fisher’s exact test. Report relative risk. 2. Secondary analyses: unadjusted Cox proportional analysis, KM curves, adjusted logistic regression |
Secondary outcomes-categorical | Chi-square or Fisher’s exact test. Report relative risk | Chi-square or Fisher’s exact test. Report relative risk |
Secondary outcomes-continuous | Generalized linear mixed models. Report beta estimate | Generalized linear mixed models. Report beta estimate |
Safety outcomes and other variables | Chi-square or Fisher’s exact test. Report relative risk. For serial measurements, generalized linear mixed effect models | None |
Subgroup analyses | Chi-square or Fisher’s exact test. Report relative risk. Tests of interaction | None |
180-day follow-up | Chi-square or Fisher’s exact test for 180-day mortality. Report relative risk Generalized linear mixed models for EQ-5D-5L ad VAS. Report beta estimate | Chi-square or Fisher’s exact test for 180-day mortality. Report relative risk Generalized linear mixed models for EQ-5D-5L ad VAS. Report beta estimate |