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
Before that, he was executive editor at Thomson Reuters Digital, Sunday Business Editor at The New York Times, and Assistant Managing Editor at Fortune
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Long-term stability is best maintained at -20C to -80C to limit thermal degradation