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The non-inferiority (NI) in increased CV risk between SEM and placebo was concluded if the upper bound of the two-sided 95% CI of the for SEM versus placebo was less than 1.8 for time to first occurrence of MACE, in accordance with the FDA guidance on the development of a new antidiabetic therapy to treat T2DM

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95% confidence interval [CI] 1.262.13)

That matters because alcohol does not affect the body in isolation

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