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The same FDA document mandates post-marketing trials to demonstrate that the novel agent does not increase cardiovascular risk by more than 30% compared to placebo (henceforth these trials were named cardiovascular outcome trial), if premarketing studies did not already demonstrate this

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do not return unused solution to the original vial or attempt further storage Outer cardboard packaging may be disposed of in household waste or recycling in accordance with local policy, unless your trial team instructs otherwise Arrange a sharps bin and collection service via your GP surgery, local council, or as directed by your clinical trial team