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The study also reported inconsistent potency among the compounded tirzepatide samples, with some containing as little as 43 percent of the drug amount listed on the label

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"We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data." FDA noted that two of the nine randomized subjects who received the investigational product were not eligible under the enrollment criteria

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