Variables | Intention-to-treat cohort | Per Protocol cohort |
---|---|---|
Baseline characteristics | No statistical comparisons will be performed | None |
Intervention and co-interventions | Chi-square, Fisher’s exact test, Mann-Whitney U test, t test as applicable | None |
Primary outcome | 1. Primary analysis: chi-square. Report relative risk. Generalized linear mixed model (GLMM) incorporating center/site as random effect. Report as adjusted relative risk. If a significant difference detected: relative risk reduction, absolute risk reduction and number needed to treat (or harm) will be reported 2. Secondary analyses: unadjusted Cox proportional analysis, Kaplan-Meier (KM) curves, adjusted Cox proportional analysis | 1. Primary analysis: chi-square and relative risk. Generalized linear mixed model (GLMM) incorporating center/site as random effect. Report as adjusted relative risk. If a significant difference detected: relative risk reduction, absolute risk reduction and number needed to treat (or harm) will be reported. 2. Secondary analyses: unadjusted Cox proportional analysis, KM curves, adjusted Cox proportional analysis |
Secondary outcomes | Chi-square. Report relative risk | None |
Subgroup analyses | Chi-square. Report relative risk | None |