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It means that anyone using it should understand they are in largely uncharted territory and proceed with appropriate caution and monitoring

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At baseline and at weeks 8 and 12, a clinician should assess fasting insulin and HOMA-IR (the homeostasis model assessment of insulin resistance, a calculated index derived from fasting glucose and insulin), HbA1c, high-sensitivity C-reactive protein as an inflammatory marker, and body composition by DEXA scan or bioelectrical impedance