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The FDA applied a four-part statutory test under 21 CFR 216.23(c): physical and chemical characterization, historical compounding use, evidence of effectiveness, and safety
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Beyond its immune-related roles, tryptophan is involved in hepatic function, specifically in the synthesis of niacin (vitamin B3), which is essential for energy metabolism and DNA synthesis (Bouma et al., Similar to GWS and ME/CFS, disruptions in purine metabolism are suspected to play a role in the pathophysiology of FM
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