Statistical methods for primary and secondary outcomes {20a}
No testing of statistical hypotheses is planned; descriptive statistics will be provided for each endpoint; therefore, both trials are exploratory in nature. In the 1366.0021 trial, the endpoints will be investigated in comparison to placebo; however, it is not planned to test a statistical hypothesis with regard to these variables in a confirmatory matter. The primary endpoint analysis will use a restricted maximum likelihood-based approach using a mixed model with repeated measurements to obtain adjusted means for the treatment effects. This will include the fixed categorical effects of treatment at each visit, the use of NSBBs or carvedilol at baseline and the continuous effects of baseline HVPG at each visit (Table 