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Monitoring Strategy Baseline (before starting): Complete pain assessment with validated tools Neurological examination Basic metabolic panel, HbA1c (if diabetic), vitamin B12, TSH INR if on warfarin Cardiovascular risk assessment Ongoing: Pain assessment every 4-8 weeks initially, then every 12 weeks INR weekly 2 weeks then monthly if on warfarin Neurological examination every 6-12 months Annual laboratory monitoring for long-term use 4

Administration of GEP44 resulted in potent anorectic effects in two-to-five-day treatment studies in both lean and diet-induced obese (DIO) rats

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