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Across all six studies, the safety findings were consistent: no serious adverse events, no immunogenic responses, no changes in IGF-1, no glucose or insulin disruption

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Lactic acidosis portends a poor prognosis (by Kings College Hospital (KCH) criteria), and the mechanism of lactic acidemia is two-fold: NAPQI being present in excess and causing mitochondrial dysregulation, followed in subsequent hours by tissue hypoxia and decreased hepatic metabolism and clearance of lactate, leading to a two-hit effect on worsening of the lactic acidosis condition