To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate

Number of participants with 50 percent (%) reduction of pruritus determined by visual analogue scale (VAS) score

The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10-centimeter (cm) line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

Time frame: Up to 60 months

Number of participants reporting all-cause mortality

Time frame: Up to 60 months

Number of participants with Adjudicated Liver Related Clinical Outcomes - Liver transplant

Time frame: Up to 60 months

Number of participants with Adjudicated Liver Related Clinical Outcomes - Progression to hepatic decompensation

Time frame: Up to 60 months

Number of participants with Adjudicated Liver Related Clinical Outcomes - Model for End-Stage Liver Disease (MELD) Score ≥15

MELD is a scoring system for assessing the severity of chronic liver disease and to assess prognosis and suitability for liver transplantation. It uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores 10-19=6.0% mortality; Score 9 or less=1.9% mortality. Higher scores indicated greater disease severity. Adjudication was performed under the review of HSAC of all available data for each identified participant to determine liver injury status.

Time frame: Up to 60 months