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This example assumes a simple parallel design in which the sponsorapplicant-defined protocol specifies the following information. All subjects are to be screened for 7 days prior to randomization into 3 protocol groups:

• Group 1 is a control group of 20 subjects, 10 male and 10 female, dosed with vehicle once per day for 28 days.
• Group 2 is a low-dose group of 20 subjects, 10 male and 10 female, dosed at 100 mg/kg once per day for 28 days.
• Group 3 is a high-dose group of 20 subjects, 10 male and 10 female, dosed at 500 mg/kg once per day for 28 days.

There are no other experimental factors of interest specified in the study design. This example corresponds to TE Example 1 (see Section 7.2.1.2, Examples for Trial Elements (TE) Domain Model) and TS Example 1 (Section 7.4.1.2, Example for Trial Sets (TX) Domain Model). In this case, the design consists of 3 trial arms, because there are 3 distinct sequences of elements, depicted as follows: