Safety population (SAF)
SECONDARY, REGRESSIONS
This dataset includes all transplanted subjects for whom at least one follow-up safety data is available. This population will be used for safety analyses.The primary population of interest will be the FAS.Descriptive summary statistics for continuous variables will include the number of observations (The primary endpoint will be expressed as the total number of cases in each group and in percentages, with a 95% confidence interval. The categorical variables of the secondary endpoints will also be expressed as the total number of cases in each group and in percentages with a 95% confidence interval.Categorical variables will be compared between the two study arms using the chi-squared test or the Fisher’s exact test, as appropriate. The continuous variables of the secondary endpoints will be compared using the Mann–Whitney In order to take into account the potential effects of confounders on the primary endpoint, univariate and multivariate logistic regressions will be performed.90-day morbidity and mortality will be studied using a Kaplan–Meier analysis and comparison between groups will be performed using the log-rank test.A 