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AAV vectors are generally safe at therapeutic doses eight AAV-based gene therapies have been FDA-approved as of 2024 but at high doses, above roughly 10^14 viral genomes per kilogram, the literature documents immune reactions, liver toxicity, and in rare cases, genotoxicity

A key consideration in this approach is the impact of continuous Exe4 secretion on endogenous hormone regulation, particularly GLP-1 and glucagon

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