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The sNDA was based on results from the Phase 3, double-blind, parallel-group, placebo-controlled cardiovascular outcomes trial, SOUL. The trial reported a 14% reduction in the risk of MACE compared to placebo when added to standard of care in patients with T2DM and established CVD and/or CKD

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Key Points Laboratory Values Comment Green tea hepatotoxicity typically presents with jaundice and an acute viral hepatitis-like syndrome, and a markedly hepatocellular pattern of serum enzyme elevations and rapid improvement upon stopping

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Treatments with the capacity to slow down the progression of AGA, or even to bring it to a halt, and at the same time dont come with side effects are consequently highly sought for