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After one-third of the study participants have been enrolled and completed follow-up, the DSMBs will review the data and make recommendations concerning continuation, modification or termination of the study due to unexpectedly large beneficial effects or serious side effects and can suggest extension of the trial should the primary outcomes occur less often than anticipated

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While evidence for exposure, detection in human matrices, and biological activity is growing, these deficits still hinder robust cross-study comparisons and clinically meaningful quantitative risk assessment

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the comparison is mechanistic only

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