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Reviews published by the National Institutes of Health caution that while patients often report feeling better, placebo effects and short-term hydration may explain some of the improvements

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In such cases, clinical evaluation by a doctor can help determine whether in-clinic procedures are appropriate

[4] SAM can increase the risk of manic episodes in people who have bipolar disorder

FDA approval requires formal clinical trials, safety and efficacy review, labeling approval, and manufacturing validation under a New Drug Application (NDA) or Biologics License Application (BLA)