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Review of all the medications, family history, and personal history of cancers, drug and alcohol use, bleeding problems, and other medical conditions (rheumatic diseases, liver problems, kidney disease) needs to be included in this evaluation

Injectable routes carry a particular concern for immunogenicity from peptide aggregation and impurities, and FDA noted the available certificates of analysis for AOD-9604 bulk drug substances did not consistently control for impurities, aggregates, or microbial limits

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