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Conversely, the Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial (REDUCEIT), which included over 50% of participants with diabetes, demonstrated that daily supplementation with 4 g of icosapent ethyl (a highly purified and stable eicosapentaenoic acid ethyl ester) significantly reduced cardiovascular risk [336]

These can include stomach ulcers, gastritis, and even stomach cancer

However, the FDA repeatedly stated it "cannot determine the adequacy" of many responses or found them "not adequate." Regulatory consequences FDA warned that "failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice

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