- The patient has liver impairment defined by elevated liver stiffness and elevated liver enzymes at the Screening Visit (both criteria have to be fulfilled): liver stiffness (LS) as measured by Fibroscan >6 kPa, elevated transaminases (AST or ALT). Transaminase levels up to 5 times the upper limit of the reference range and γGT levels up to 10 times the upper limit of the reference range are allowed. At the discretion of the investigator, transaminase levels >5 times the upper limit of the reference range and γGT >10 times the upper limit of the reference range can be allowed if considered habitual for the patient, either confirmed by patient records or a repeat measurement during the Screening Period