| Outcome Measures: |
Primary: Incidence of liver inflammation or injury greater than 3 times the upper limit of normal, as monitored by serum alanine aminotransaminase elevation., At All Visits | Secondary: Incidence of alanine aminotransferase greater than 8 times the upper limit of normal., At All Visits|Incidence of alanine aminotransferase greater than 3 times the upper limit of normal but less than or equal to 8 times the upper limit of normal on 4 consecutive measurements within a 3-month period., At All Visits|Incidence of alanine aminotransferase greater than 3 times the upper limit of normal and total bilirubin greater than 2 times the upper limit of normal., At All Visits|Change from Baseline or greater than 1.5 times the upper limit of normal (whichever is greater) in the level of alanine aminotransferase, aspartate aminotransferase, total or direct bilirubin, alkaline phosphatase or gamma-glutamyl transpeptidase., At All Visits
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