| Outcome Measures: |
Primary: Change in glycosylated hemoglobin (HbA1c) from baseline to Week 26, 26 weeks|Change in the weighted average of standardized AST, CK-18, and HbA1c values (standard deviations) from baseline to Week 26, This is a single composite outcome measure. This is derived by standardizing the values of AST, CK-18, and HbA1c by subtracting the respective study population means and dividing by respective study population standard deviations at each time point; averaging these standardized AST, CK-18,and HbA1c values (or z-scores) for a given patient at each time point; and then computing the difference from baseline to week 26 with respect to these averages., 26 weeks | Secondary: Time to first event of death, adjudicated nonfatal MI or USA hospitalization, adjudicated hospital admission for HF, or adjudicated nonfatal ischemic stroke., through study completion, an expected average of 15 months|Time to first event of death or adjudicated non-fatal MI or USA hospitalization, adjudicated hospital admission for HF, adjudicated nonfatal ischemic stroke, or liver event in all randomized subjects., A liver event consists of ascites (confirmed by paracentesis or abdominal imaging), hepatic encephalopathy (defined clinically), variceal hemorrhage (confirmed by endoscopy), or liver transplant., through study completion, an expected average of 15 months
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