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There are no other experimental factors of interest specified in the study design. In this case, the design consists of 6 trial arms, because there are 6 distinct sequences of elements, as depicted in the following figure.
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| SENDIG:Figure. Example Trial 1 DesignSENDIG: |
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| Figure. Example Trial 1 Design |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
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| 1 | TDM1 | TE | SCRN | Screen | Start of PretreatmentPre-exposure | 1 week after start of Element | P7D | | 2 | TDM1 | TE | TRT01 | Vehicle Control | First day of dosing with vehicle control | 28 days after start of Element | P28D | | 3 | TDM1 | TE | TRT02 | 100 mg/kg Drug A, once daily | First day of dosing with 100 mg/kg Drug A | 28 days after start of Element | P28D | | 4 | TDM1 | TE | TRT03 | 500 mg/kg Drug A, once daily | First day of dosing with 500 mg/kg Drug A | 28 days after start of Element | P28D | | 5 | TDM1 | TE | RECO | Recovery | First day of Recovery | 7 days after start of Element | P7D | |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
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| 1 | TDM1 | TA | 01 | Control | 1 | SCRN | Screen | Randomized to Group 1 | PRE-TREATMENTEXPOSURE | | 2 | TDM1 | TA | 01 | Control | 2 | TRT01 | Vehicle Control |
| TREATMENTEXPOSURE | | 3 | TDM1 | TA | 01R | Control w/ Recovery | 1 | SCRN | Screen | Randomized to Group 1, planned for recovery | PRE-TREATMENTEXPOSURE | | 4 | TDM1 | TA | 01R | Control w/ Recovery | 2 | TRT01 | Vehicle Control |
| TREATMENTEXPOSURE | | 5 | TDM1 | TA | 01R | Control w/ Recovery | 3 | RECO | Recovery |
| RECOVERY | | 6 | TDM1 | TA | 02 | Low Dose | 1 | SCRN | Screen | Randomized to Group 2 | PRE-TREATMENTEXPOSURE | | 7 | TDM1 | TA | 02 | Low Dose | 2 | TRT02 | 100 mg/kg Drug A |
| TREATMENTEXPOSURE | | 8 | TDM1 | TA | 02R | Low Dose w/ Recovery | 1 | SCRN | Screen | Randomized to Group 2, planned for recovery | PRE-TREATMENTEXPOSURE | | 9 | TDM1 | TA | 02R | Low Dose w/ Recovery | 2 | TRT02 | 100 mg/kg Drug A |
| TREATMENTEXPOSURE | | 10 | TDM1 | TA | 02R | Low Dose w/ Recovery | 3 | RECO | Recovery |
| RECOVERY | | 11 | TDM1 | TA | 03 | High Dose | 1 | SCRN | Screen | Randomized to Group 3 | PRE-TREATMENTEXPOSURE | | 12 | TDM1 | TA | 03 | High Dose | 2 | TRT03 | 500 mg/kg Drug A |
| TREATMENTEXPOSURE | | 13 | TDM1 | TA | 03R | High Dose w/ Recovery | 1 | SCRN | Screen | Randomized to Group 3, planned for recovery | PRE-TREATMENTEXPOSURE | | 14 | TDM1 | TA | 03R | High Dose w/ Recovery | 2 | TRT03 | 500 mg/kg Drug A |
| TREATMENTEXPOSURE | | 15 | TDM1 | TA | 03R | High Dose w/ Recovery | 3 | RECO | Recovery |
| RECOVERY |
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As noted, there are 6 distinct trial sets. The experimental factors of interest are the dose level to be received during the treatment period exposure period and whether the subjects are planned for termination on day 28 or will enter a recovery period.
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