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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

It does not replace those systems or override pathological processes that require medical treatment

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Storage: Store at controlled room temperature of 20C to 25C (68F to 77F)

What should you monitor in terms of side effects