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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

This increase was directly linked to tesofensine and any external factors were excluded as possible causes

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With targeted, individualized nutrient therapy, copper levels can be safely brought into the normal range typically between six to nine months depending on the level of severity and patient compliance

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