Analysis method for primary and secondary outcomes
REGRESSION, SECONDARY
In the primary analysis, the effect of treatment on the primary endpoint will be measured by means of the odds ratio estimated through an unadjusted logistic regression model including a dummy variable for treatment group. Moreover, as part of the sensitivity analyses, a multivariable logistic regression model will be performed. Survival outcome will be analyzed using Kaplan–Meier survival analysis and log-rank test. Univariate and multivariable Cox proportional hazards models will also be applied. Additionally, the joint modeling omnibus test [Country will be included as a random factor in the LME models. Clustered standard errors by country will be used in logistic and Cox regression models to obtain robust estimates. All primary and secondary analyses will be carried out on both ITT and per-protocol populations.