Explanation for the choice of comparators {6b}
non-cholestatic liver disease, alcohol-related cirrhosis
In the 1366.0021 trial, placebo will be used as a comparator and will be run on top of the current standard of care (i.e. concomitant stable doses of NSBBs or carvedilol, or previous variceal ligation). The 1366.0029 trial is open label, and there will be no direct comparator; it is a proof-of-concept study in non-cholestatic liver disease aetiologies other than alcohol-related cirrhosis. Results of this trial will be compared with 8-week data from the 1366.0021 trial.