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Our data show that, as compared with placebo or with other antidiabetic regimens, treatment with rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that was of borderline significance.

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The prespecified secondary endpoints, in order of priority, were: time to the first event of death from any cause, myocardial infarction (excluding silent myocardial infarction), and stroke (main secondary endpoint in rest of this report); cardiovascular death; and time to individual components of the primary composite endpoint.

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