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Biomaterials 33 , 15091519 (2012)

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Red flags that should stop the protocol Certain findings should trigger immediate discontinuation of one or both compounds: IGF-1 levels exceeding the age-appropriate upper normal limit on two consecutive tests Fasting glucose rising above 126 mg/dL or HbA1c above 6.5% (indicating new-onset diabetes) Liver enzymes (ALT or AST) exceeding three times the upper limit of normal Persistent severe nausea, vomiting, or abdominal pain suggesting gastroparesis or pancreatitis New or worsening carpal tunnel syndrome symptoms Peripheral edema that does not resolve with fluid management Any sign of an allergic or hypersensitivity reaction These red flags are not exhaustive