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Previous premature discontinuation from IP in the parent study\u002Fsub-study.\n3. ALT \\>5 × ULN; or ALT\\>3 × ULN and bilirubin \\>1.5 × ULN (with \\>35% direct bilirubin) in the screening liver chemistry test result.\n4. Participants with known active hepatitis B infection (as indicated by a positive HBsAg and\u002For quantifiable HBV DNA). Participants negative for HBsAg but positive for anti-HBc and positive for anti-HBs (past and\u002For current evidence) are immune to HBV and are not excluded.\n5. Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator).\n6. Known history of cirrhosis with or without viral hepatitis co-infection.\n7. 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