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With respect to any costs/burdens unrelated to data submission, we refer readers to the Regulatory Impact Analysis in section XXVI.C.3 of this final rule with comment period

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Effects of the Sema + Cagrilintide Blend: Dual-Pathway Weight Loss: Investigated for the ability of combined GLP-1 and Amylin agonism to produce superior weight loss compared to monotherapy in rodent models