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Adverse Reactions/Side Effects The following serious adverse reactions are described elsewhere in the labeling: Severe Optic Atrophy in Patients with Leber’s Disease [see Warnings and Precautions (5.1)]
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Glycemic category was determined by investigators on the basis of available information (for example, medical records, concomitant medication, and blood glucose variables) and in accordance with American Diabetes Association criteria, 30 which for prediabetes includes fasting plasma glucose levels of 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) or HbA 1c levels of 5.7–6.4% (39–47 mmol/L), and for type 2 diabetes includes fasting plasma glucose levels of ≥126 mg/dL (7.0 mmol/L) or HbA 1c levels ≥6.5% (48 mmol/L)
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