Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
The handling of missing PK data in both trials will be performed according to the relevant BI internal procedures. In the 1366.0021 trial, the mixed effect model for the primary endpoint will handle missing data based on a likelihood method under the ‘missing at random’ assumption. No imputation of missing data is planned for the remaining endpoints of either trial or the interim analysis of week 8 HVPG data in the 1366.0021 trial. The decision to exclude patients from analysis sets due to protocol deviations will be taken during the course of the trials and finalised at the last report planning meeting.