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FDA concluded that the small study could not establish whether the observed tendencies were clinically meaningful
To compare the in vitro DNA damaging activity of different NAs, a predefined critical effect size (CES) of 100% was chosen, representing a twofold increase in median-based mean TI of the treated cells over the mean TI value of the respective control
Independent, third-party testing for identity and purity is the standard that separates a medical-grade compound from a bag of powder with a label
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