Interim analyses {21b}
SECONDARY
In the 1366.0021 trial, an interim analysis is planned after the first 60 patients (20 per dose group) have completed the first 8 weeks of treatment and the week 8 HVPG procedure. All available data, except data for the primary endpoint and one secondary endpoint (week 8 HVPG), will be analysed the same way as the final analysis. The percentage change in HVPG from baseline after 8 weeks of treatment will be analysed by ANCOVA. The interim analysis will be performed by an independent statistical and programming team; there will be no changes in trial design as a result of the interim analysis.