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other measures regressed Between-Group Comparison: No significant differences at either 8 or 12 weeks Improvements were comparable in magnitude across both groups, raising questions about the role of placebo response in FMS treatment Adverse Events Only one minor adverse event was reported in the IVMT group, indicating a favorable safety profile

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Body of the response should contain systemic corrections for underlying issues, corrective actions for specific instances, steps for identifying, examining, and correcting similar problems, Impact assessment on manufactured products interim compliance measures, Realistic timelines for corrections, attachments verifying implemented actions