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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]

Cassetta, L

This requirement can lead to increased healthcare costs and may not be feasible for those with limited access to medical services

The main risks stem from its unapproved status and potential for improper compounding

we must consider the unique dynamics of the developing brain and proceed cautiously until thorough safety and efficacy parameters have been established

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