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As a result, the incidence of MACE (major adverse cardiovascular event) was reduced by 21% as compared to placebo

Lembo 2003)

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Of the 165, 74 were based on observations from an on-site inspection, 16 letters stemmed from tested samples, and three from a records request under section 704(a)(4) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (referred to as 704(a)(4) requests in this article)