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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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Wrong temps cause ice crystal damage, precipitation, or accelerated hydrolysis that compromises experiment validity

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Room-temperature medication is less irritating to tissue than cold liquid, which can cause brief stinging

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