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While results are required to be submitted no later than 12 months after the Primary Completion Date, Collins notes for certain applicable clinical trials, the period is up to three years. If the drug or biologic was not approved, licensed, or cleared by the FDA, the results may not be due at all

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enalapril is activated to enalaprilat, codeine is changed to morphine) or unchanged (diazepam is changed to nordiazepam)

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