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FDA staff identified a lack of published efficacy evidence for epitalon in patients with insomnia and raised concerns involving characterization, peptide-related impurities, immunogenicity, and uncertain long-term risk

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Indeed, in both studies, the highest frequency of TEAEs was in the normal function groups, possibly owing to the smaller sample sizes in the more severe impairment groups, or alternatively because participants with more serious health concerns, such as those with severe renal or hepatic impairment, may be less likely to notice or report mild or moderate TEAEs, as observed in populations with cancer [21]

This preparation is contraindicated in patients who are sensitive to cobalt and/or vitamin B12

[DOI] [PMC free article] [PubMed] [Google Scholar] 3.Sjstrm L, Narbro K, Sjstrm CD, Karason K, Larsson B, Wedel H, et al