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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).

te.xpt

te.xpt

RowSTUDYIDDOMAINETCDELEMENTTESTRLTEENRLTEDUR
1EXP7TEPRETESTPretreatment Feeding PeriodStart of pretreatment periodWhen subject's body weight is at least 750 g
2EXP7TECONTROLControl PeriodAfter completion of PRETEST Element30 days after start of ElementP30D
3EXP7TETREAT2100 mg/kg Drug A, once dailyAfter completion of PRETEST Element30 days after start of ElementP30D
4EXP7TETREAT3200 mg/kg Drug A, once dailyAfter completion of PRETEST Element30 days after start of ElementP30D
5EXP7TETREAT4300 mg/kg Drug A, once dailyAfter completion of PRETEST Element30 days after start of ElementP30D
6EXP7TETREAT5100 mg/kg Drug B, twice daily doses of 50 mg/kg eachAfter completion of PRETEST Element30 days after start of ElementP30D
7EXP7TETREAT6200 mg/kg Drug B, twice daily doses of 100 mg/kg eachAfter completion of PRETEST Element30 days after start of ElementP30D
8EXP7TETREAT7400 mg/kg Drug B, twice daily doses of 200 mg/kg eachAfter completion of PRETEST Element30 days after start of ElementP30D
9EXP7TERECOVERYRecovery PeriodAfter last dose with treatment or vehicle control14 days after start of ElementP14D
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