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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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Those with diseases that affect the gut, such as Crohns disease or celiac disease, are also at risk ( Summary Those at greatest risk of vitamin B12 deficiency are vegans and vegetarians, who get little to no B12 from the diet