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FDA's own scientists recommended against it, citing inadequate physicochemical characterization, immunogenicity risk from aggregation and peptide-related impurities, and insufficient evidence of effectiveness

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The evaluation of these doses was performed in various periods, ranging from 20 weeks to 68 weeks

Each batch undergoes independent analytical testing and is accompanied by batch-specific verification documentation

First, if the titration protocol calls for a dose increase at week two or four, the higher dose amplifies all three receptor pathways

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