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The assay was validated according to local procedures: the FDA 2018 guideline on validation of bioanalytical methods [17], the EMA 2011 guideline on validation of bioanalytical methods [18] and current practice

Verdict: Limited evidence the available human safety data consists of very small pilot studies, no long-term follow-up, unresolved FDA-documented concerns, and at least one theoretical risk that has never been formally evaluated in humans [4][10][1517]

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