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Psychiatry 170 , 599608 (2013)

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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

doi: 10.1038/nrcardio.2014.59 53 SarzaniRGiuliettiFDi PentimaCSpannellaF