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"Your explanations, when taken into consideration with the violations described above and your failure to adequately address your noncompliance, suggest systemic failures with your surveillance, receipt, evaluation, and reporting of ADEs to FDA," the agency wrote

Those with a score of 21 to 26 are considered to have mild Alzheimers disease, and the majority of participants in this study had a score of about 22, although some had scores down to 17, indicating moderate Alzheimers, Edison said

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