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In hepatocytes, acetyl-CoA is used as a substrate for ketogenesis [37] during extended fasting or limited carbohydrate availability, and the liver adapts to dwindling glycogen stores by increasing -oxidation and by converting the acetyl-CoA to ketone bodies, primarily acetoacetate and its chemically reduced analog -hydroxybutyrate [38]
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The FDA also agreed to change a full clinical hold for the trial to a partial clinical hold pending review and approval of the company's proposed protocol for a 6-month, Phase I study to assess the potential relevance of adverse findings observed in long-term animal studies of metadoxine in relation to human exposure, Alcobra said
Larsson, L
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