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It failed to gain approval for obesity treatment following Phase II clinical trials in the mid-2000s, and no regulatory body has since approved it for any human indication

Studies have shown that people can have high or normal B12 levels in the blood and actually show virtually no B12 in the spinal fluid, meaning the B12 is not being transported from the blood stream into the cells where it should be absorbed and used

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They stated that there was an increase in IgG antigliadin antibodies in 19.3% of children who did not follow a gluten-free diet, and 4050% of individuals with ASD had gluten intolerance [32]

Overall, while preclinical findings provide important mechanistic insights, clinical implementation must be guided by realistic exposure levels, safety margins, and well-designed human trials