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Allocation: Randomized, Interventional Model: Parallel Assignment, Masking: Quadruple
Primary outcome measures:
The proportion of Obeticholic Acid treated patients achieving at least one stage of liver fibrosis improvement with no worsening of NASH achieving NASH resolution with no worsening of liver fibrosis, Death (all cause), model of end stage liver disease (MELD) score ≥15, liver transplant, ascites requiring medical intervention, histological progression to cirrhosis, hospitalization (as defined by a stay of ≥24 hours) for onset of: variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis.
Between Dec 9, 2015, and Oct 26, 2018, 1968 patients with stage F1–F3 fibrosis were enrolled and received at least one dose of study treatment; 931 patients with stage F2–F3 fibrosis were included…