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In the companys supplemental NDA, Neurocrine included data from the Phase III KINECT-HD trial and the ongoing KINECT-HD2 open-label study to establish the safety and efficacy of Ingrezza in the proposed indication

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For every 1 gram daily of carnitine supplementation, up to 4 grams, the results showed a significant mean reduction in the following compared with controls: BMI: 0.37 kg/m3 Fasting plasma glucose: 3 mg/dL HbA1c: 0.16% LDL cholesterol: 4 mg/dL Total cholesterol: 5 mg/dL Triglycerides: 6 mg/dL The greatest reductions in BMI were observed at 2 grams daily whereas serum triglycerides, total cholesterol, and fasting plasma glucose had the greatest improvements at 4 grams daily (Mirrafiei 2024)

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