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- Group 1 is a control group of 20 subjects, 10 male and 10 female, which are to be dosed with vehicle once per day for 14 days, given a 7-day rest period, dosed again with vehicle once per day for 14 days, given a second 7-day rest period, and dosed with vehicle once per day for the final 14 days.
- Group 2 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 50 mg/kg of product/intervention article once per day for 14 days, given a 7-day rest period, dosed at 800 mg/kg once per day for 14 days, given a second 7-day rest period, and dosed at 400 mg/kg of product once per day for the final 14 days.
- Group 3 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 400 mg/kg of product/intervention article once per day for 14 days, given a 7-day rest period, dosed at 50 mg/kg of product once per day for 14 days, given a second 7-day rest period, and dosed at 800 mg/kg of product once per day for the final 14 days.
- Group 4 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 800 mg/kg of product/intervention article once per day for 14 days, given a 7-day rest period, dosed at 400 mg/kg of product once per day for 14 days, given a second 7-day rest period, and dosed at 50 mg/kg of product once per day for the final 14 days.
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This example shows the start and end rules and durations for the different product/intervention article exposure elements, indicating whether they follow a product exposure or nonexposure element.
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