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In explaining its decision, the agency flagged concerns about complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization, the potential for aggregation and a lack of human safety data

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Carcinogenesis 28:193745, PMID: 17698970 Neuschwander-Tetri BA, Bellezzo JM, Britton RS, Bacon BR, Fox ES (1996) Thiol regulation of endotoxin-induced release of tumour necrosis factor alpha from isolated rat Kupffer cells

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