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| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
|---|
| 1 | TDM2 | TA | 1 | Control | 1 | SCRN | Screen | Randomized to Group 1 | ScreenPRE-TREATMENT | | 2 | TDM2 | TA | 1 | Control | 2 | TRT01 | Vehicle Control |
| TreatmentTREATMENT | | 3 | TDM2 | TA | 2 | 100 mg/kg | 1 | SCRN | Screen | Randomized to Group 2 | ScreenPRE-TREATMENT | | 4 | TDM2 | TA | 2 | 100 mg/kg | 2 | TRT02 | 100 mg/kg Drug A |
| TreatmentTREATMENT | | 5 | TDM2 | TA | 3 | 500 mg/kg | 1 | SCRN | Screen | Randomized to Group 3 | ScreenPRE-TREATMENT | | 6 | TDM2 | TA | 3 | 500 mg/kg | 2 | TRT03 | 500 mg/kg Drug A |
| TreatmentTREATMENT |
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Trial Sets
Assuming that the protocol also specifies that subjects with blood sampling for TK analysis are experimentally distinct, the factors of interest are the treatment levels and whether the subject is sampled for TK analysis; this leads to 6 trial sets.
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