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This example includes the nonfixed duration for pretest phase where the end rule is not a definite time, but when the subject achieves a specified body weight. In order to completely understand the experimental design of a trial, the TA and TS datasets are needed (see Section 7.3, Trial Arms, and Section 7.4, Trial Sets).
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Row | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
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1 | EXP7 | TE | PRETEST | Pretreatment Feeding Period | Start of pretreatment period | When subject's body weight is at least 750 g |
| 2 | EXP7 | TE | CONTROL | Control Period | After completion of PRETEST Element | 30 days after start of Element | P30D | 3 | EXP7 | TE | TREAT2 | 100 mg/kg Drug A, once daily | After completion of PRETEST Element | 30 days after start of Element | P30D | 4 | EXP7 | TE | TREAT3 | 200 mg/kg Drug A, once daily | After completion of PRETEST Element | 30 days after start of Element | P30D | 5 | EXP7 | TE | TREAT4 | 300 mg/kg Drug A, once daily | After completion of PRETEST Element | 30 days after start of Element | P30D | 6 | EXP7 | TE | TREAT5 | 100 mg/kg Drug B, twice daily doses of 50 mg/kg each | After completion of PRETEST Element | 30 days after start of Element | P30D | 7 | EXP7 | TE | TREAT6 | 200 mg/kg Drug B, twice daily doses of 100 mg/kg each | After completion of PRETEST Element | 30 days after start of Element | P30D | 8 | EXP7 | TE | TREAT7 | 400 mg/kg Drug B, twice daily doses of 200 mg/kg each | After completion of PRETEST Element | 30 days after start of Element | P30D | 9 | EXP7 | TE | RECOVERY | Recovery Period | After last dose with treatment or vehicle control | 14 days after start of Element | P14D |
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