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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 |
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| 1 | TDM4 | TA | 1 | Control | 1 | SCRN | Screen | Randomized to Group 1 | ScreenPRE-TREATMENT | | 2 | TDM4 | TA | 1 | Control | 2 | CONTROL | Control |
| TreatmentTREATMENT | | 3 | TDM4 | TA | 1R | Control + Recovery | 1 | SCRN | Screen | Randomized to Group 1 with Recovery | ScreenPRE-TREATMENT | | 4 | TDM4 | TA | 1R | Control + Recovery | 2 | CONTROL | Control |
| TreatmentTREATMENT | | 5 | TDM4 | TA | 1R | Control + Recovery | 3 | RECO | RecoveryRecovery |
| RECOVERY | | 6 | TDM4 | TA | 2 | Low Dose | 1 | SCRN | Screen | Randomized to Group 2 | ScreenPRE-TREATMENT | | 7 | TDM4 | TA | 2 | Low Dose | 2 | T5 | 5 mg/kg Drug A |
| TreatmentTREATMENT | | 8 | TDM4 | TA | 3 | High Dose | 1 | SCRN | Screen | Randomized to Group 3 | ScreenPRE-TREATMENT | | 9 | TDM4 | TA | 3 | High Dose | 2 | T100 | 100 mg/kg Drug A |
| TreatmentTREATMENT | | 10 | TDM4 | TA | 3R | High Dose + Recovery | 1 | SCRN | Screen | Randomized to Group 3 with Recovery | ScreenPRE-TREATMENT | | 11 | TDM4 | TA | 3R | High Dose + Recovery | 2 | T100 | 100 mg/kg Drug A |
| TreatmentTREATMENT | | 12 | TDM4 | TA | 3R | High Dose + Recovery | 3 | RECO | RecoveryRecovery |
| RECOVERY |
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Trial Sets
In this study there are multiple experimental factors of interest: the treatment level given during the treatment epoch (3 levels), the feeding regimen of the subjects (ad libitum vs. restricted feeding), whether the subjects are to be used for TK analysis, and whether the subjects will be terminated at the end of the dosing period or experience a recovery period. The combination of these factors (3x2x2x2) could lead to up to 24 possible combinations or sets; however, upon careful reading of the description there are 14 sets that will actually be part of the study:
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