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Endothelial dysfunction—marked by reduced nitric oxide (NO) bioavailability, impaired vasodilation, and increased vascular permeability—is a primary feature in both microvascular and macrovascular diabetic complications [25]

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In its review, the FDA specifically flagged missing bioburden, endotoxin, and impurity-characterization data in vendor certificates, along with immunogenicity concerns tied to peptide aggregation