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There are no other experimental factors of interest specified in the study design. This example corresponds to Trial Elements Example 1 (see Section 7.2.1.2, Examples for Trial Elements (TE) Domain Model) and the Trial Arms example (see Section 7.3.1.2, Example for Trial Arms (TA) Domain Model). There are only 3 trial sets in this scenario, because there are no nontreatment factors to consider. In this example, the sponsor has chosen to provide a small amount of additional information about each trial set, including the associated arm code, sponsor-defined protocol group number, control group type, group label, and dose level and units, and the sponsor has made the assumption that male and female animals will be compared separately when relevant.

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