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These ideas rely on data drawn from other studies
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While safety monitoring was comprehensive, the trials were not specifically designed to detect rare adverse effects that might occur at rates lower than 1-2%, which would require much larger participant numbers
Given the emergence of COVID-19 in the second year of the study, trial visits were permitted to be conducted via telephone, during which counseling was provided and safety-related information was collected
The lack of prescription requirement places responsibility on individuals to source quality products and use them safely
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