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