Statistical methods for primary and secondary outcomes {20a}
EVENT, PBC
The data management workup and statistical analyses will be performed at Rigshospitalet, Denmark. For patients fulfilling all inclusion and exclusion criteria, the treatment groups will be compared as an intention-to-treat principle. Additional as-treated analyses will be performed.Due to post-randomization exclusions, the primary outcome will be analyzed in a modified intention-to-treat population. The primary outcome will be tested for normality, and In general, differences between group means/medians will be assessed with parametric or non-parametric statistics as appropriate. Chi-square analysis or Fisher’s exact test will be used to test differences between categorical variables. Probability of survival will be displayed using Kaplan–Meier methodology and hazard ratios with 95% confidence interval between groups assessed by Cox proportional hazard models. In case of an event or until the last patient has been followed, the patients will be censored. A two-tailed All statistical analyses will be performed in SAS (version 9.4, SAS Institute, Cary, NC, USA) and R Studio, version 1.2.5001 (RStudio Team (2020). RStudio: Integrated Development for R. RStudio, PBC, Boston, MA; URL: 