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Starting doses were conservative, with gradual increases based on safety and tolerability data from previous cohorts

If nausea is significant even with pyridoxine, the escalation may slow, holding at each dose for six or eight weeks instead of four

This personalized approach maximizes both weight loss and hormonal improvements while minimizing unnecessary trial-and-error

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Each generic drug sponsor is requested to provide sufficient details about their immunogenicity risk assessment assays to allow regulatory reviewers to determine if the methods are sufficient