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Dot plots and boxplots were created using R (v4.1.1), the ggplot2 (v3.5.1) and ggbeeswarm (v0.7.2) packages

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The consent must accurately characterize the compound as an unapproved bulk drug substance (not as an approved drug used off-label), the evidence base and its limitations, known and theoretical risks, alternatives considered, the monitoring plan, and the patients ability to decline or discontinue