 - Patients with either a medical history or evidence of cirrhosis who had any biopsy showing cirrhosis or any approved non-invasive test indicative of cirrhosis as documented in the medical source documents; OR b either of the following at screening: transient elastography score 10.5 kPa OR a Fibrotest Fibrosure score of 0.48 and an aspartate aminotransferase platelet ratio Index APRI of 1. Note: If a biopsy or non-invasive test has never been performed or if a biopsy or non-invasive test has been performed but showed no cirrhosis, then b must be followed at screening 