Sample size
fibrosis
EVENT, FIBROSIS, CHRONIC LIVER DISEASE
This was a pilot study evaluating feasibility, with the intention that results would be used to estimate the variability of the treatment effect of MVC on the ELF score. This in turn would inform the sample size calculation for an RCT to evaluate drug efficacy. We based our sample size justification for this pilot study on change in ELF score. In a previous longitudinal study in people with chronic liver disease, a unit increase of 1 in the ELF score was associated with a 2.5-fold increased risk of a liver-related event, adjusted for age and stage of fibrosis. A unit increase of 1 was therefore considered a clinically important entity [