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Zero recorded deaths in 17 years. With over 1300 studies conducted, it's considered well tolerated by humans, with no known deaths recorded in its 17 years of use in over 20 countries. Modafinil has a "very low abuse potential" with 90% of use being "off-label" by healthy individuals. "it appears to be well-tolerated, with a low rate of adverse events and a low liability to abuse."

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