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While clinical evidence 52,53 has indicated a possible elevated risk, causality has not been established
The relative increase in diagnoses other than T2DM seen among incident patients dispensed within the benefit could in turn indicate an increased off-label prescribing being done within the benefit
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Dose-related effects on the rat fetus (structural abnormalities and reduced body weight) occurred only at higher dosages, equal to or greater than 150 mg/kg (more than 2344-times the 10 mg clinical dose, based on AUC), which were associated with maternal toxicity
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