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Safety

In addition to the NDI's approval, the following preclinical and clinical safety studies have been conducted.

  1. Single dose oral toxicity study in rats (GLP study)
  2. 90-day repeated dose oral toxicity study in rats (GLP study)
  3. Bacterial reverse mutation (Ames) test (GLP study)
  4. Micronucleus test in mice (GLP study)
  5. 3-month clinical safety study
  6. Phase I clinical safety study
  7. Doping test
 

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