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"It would not establish an approved indication, standardized dose, demonstrated efficacy, or an FDA-reviewed safety profile." For FDA approval, the peptides would need to undergo large and rigorous randomized controlled trials to validate their efficacy and safety
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13 Other possible reasons for the absence of increased brain intracranial β HB levels in our study might be variability due to regional changes in the brain induced by KD, impact of concurrent antiseizure medications or MCT-oil consumption, or other unknown lifestyle factors