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Relative to comparators, the risk for any of the commonly used cardiovascular end points was estimated to be below 1.0, and for both MACE-4 and MACE-3 (myocardial infarction, stroke, and all-cause death), the upper bounds of the confidence interval calculated around the hazard ratio were decidedly 8.5 %

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The agencys risk assessment committee based its findings on two large studies of electronic records in which no association was found