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You are encouraged to report negative side effects of prescription drugs to the FDA
It is more common in women than men, and especially in Asians
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
Inadequate Disclosure of Potential Side Effects: The spa's information on potential side effects needs improvement
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The tablet is taken once a day by mouth, with no needles, no pens, and no fridge needed
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