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The example depicts a complex multifactorial trial design. The sponsorapplicant-defined protocol specifies the following information: All subjects are to be screened for 7 days prior to randomization into 3 protocol groups:

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This can be represented in the TS domain as follows. The sponsor applicant is providing the following information for each set: arm code, sponsorapplicant-defined group code, group label, dose level and units, control type, feeding regimen, toxicokinetic description, and planned number of subjects (not broken out by sex).

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