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Clinical Trials Advisor
Oct. 11, 2012 | Vol. 17 No. 20
Draft Guidance Suggests 28-Day Goal for cIAI Clinical Trials
Clinical trials of drugs to treat complicated intra-abdominal infections (cIAI) should have a primary endpoint of complete resolution of symptoms at 28 days following randomization and the absence of clinical failure, according to an FDA draft guidance.
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