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ADaM IG 1.3 - Treatment variables for trial designs
Question 1 of 12



A double-blind study has an open-label extension. In one BDS approach, both ADSL treatment variables and record-level TRTP are included:

USUBJIDAPERIODADTTRTPTRT01PTRT02P
1002105JUL2007PlaceboPlaceboDrug X 5 mg
1002217AUG2007Drug X 5 mgPlaceboDrug X 5 mg

Which analysis question does TRTP support here?





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