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IG33_TE_TE_001 IG33_TE_TE_002 IG33_TE_TE_003
Example STUDYID DOMAIN ETCD ELEMENT TESTRL TEENRL TEDUR
IG33_TE_TE_001 EX1 TE SCRN Screen Informed consent 1 week after start of Element P7D
IG33_TE_TE_001 EX1 TE RI Run-In Eligibility confirmed 2 weeks after start of Element P14D
IG33_TE_TE_001 EX1 TE P Placebo First dose of study drug, where drug is placebo 2 weeks after start of Element P14D
IG33_TE_TE_001 EX1 TE A Drug A First dose of study drug, where drug is Drug A 2 weeks after start of Element P14D
IG33_TE_TE_001 EX1 TE B Drug B First dose of study drug, where drug is Drug B 2 weeks after start of Element P14D
Example STUDYID DOMAIN ETCD ELEMENT TESTRL TEENRL TEDUR
IG33_TE_TE_002 EX2 TE SCRN Screen Informed consent 2 weeks after start of Element P14D
IG33_TE_TE_002 EX2 TE P Placebo First dose of a treatment Epoch, where dose is placebo 2 weeks after start of Element P14D
IG33_TE_TE_002 EX2 TE 5 5 mg First dose of a treatment Epoch, where dose is 5 mg drug 2 weeks after start of Element P14D
IG33_TE_TE_002 EX2 TE 10 10 mg First dose of a treatment Epoch, where dose is 10 mg drug 2 weeks after start of Element P14D
IG33_TE_TE_002 EX2 TE REST Rest 48 hrs after last dose of preceding treatment Epoch 1 week after start of Element P7D
IG33_TE_TE_002 EX2 TE FU Follow-up 48 hrs after last dose of third treatment Epoch 3 weeks after start of Element P21D
Example STUDYID DOMAIN ETCD ELEMENT TESTRL TEENRL TEDUR
IG33_TE_TE_003 EX4 TE SCRN Screen Informed Consent Screening assessments are complete, up to 2 weeks after start of Element
IG33_TE_TE_003 EX4 TE A Trt A First dose of treatment Element, where drug is Treatment A 5 days after start of Element P5D
IG33_TE_TE_003 EX4 TE B Trt B First dose of treatment Element, where drug is Treatment B 5 days after start of Element P5D
IG33_TE_TE_003 EX4 TE REST Rest Last dose of previous treatment cycle + 24 hrs At least 16 days after start of Element and WBC recovered
IG33_TE_TE_003 EX4 TE FU Follow-up Decision not to treat further 4 weeks P28D