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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

Cervicovaginal microbiota: a promising direction for prevention and treatment in cervical cancer

FL: Writing original draft

This example might be used where there is something about the trial drug that makes using a placebo difficult perhaps because it is given by injection

It supports IECs proliferation by activating ornithine decarboxylase (ODC) and increasing cellular polyamine levels, which are crucial for mucosal growth