a Liver biopsy within 2 years of Screening showing absence of cirrhosis b Fibroscan with a result of ≤ 12.5 kPa within 6 months of Baseline/Day1 In the absence of a definitive diagnosis of the presence or absence of cirrhosis by the above criteria, a liver biopsy is required. Liver biopsy results supersede the results obtained by Fibroscan or FibroTest.