Appendix A Study Activities – Run-In Period Screening (Up to 12 Enrichment Period F/U (2 Weeks) Weeks)a (6 Weeks) Dosing Period Period Wk –10, Visit Duration in –8, Weeks Until Wk Wk Wk Wk Day Wk Wk Wk Wk Wk –6, Randomization 1 1 2 4 6 7 –14 –13 –12 –4 –2 R2, R3, Wk Wk Every Final R4, 1 2 T 3 Yearly Treatment Activities S1 S2 R1 R5 R6 E1 E2 E3 E4 E5 Call Call 1 Mths Visits Visit (PD)b F1c Medical History X Xl Xl Xl Xl Xl – including questions regarding tobacco and alcohol use Complete X X Physical Exam Vital Signs X X X X X X X X X X X X X X X X (blood pressure, heart rate, weight and temperature)d Assess Limb X X X X X X X X X X X X X X X X Swellinge Blood Drawsf X X X X X X X X X X X X X X First Morning X X X X X X X X (if X Void Urine discontinued Collectionsg during dosing period only) Optional Genetic X Sample Urine Testsh X X X X X (T3 X X X only) Blood Pressure X X X X Medication Dose Adjustments
Appendix A – Study Activities Visit Duration in Weeks Until Randomization Screening (2 Weeks) Run-In Period (Up to 12 Weeks)a Enrichment Period (6 Weeks) Dosing Period F/U Period Wk –14 Wk –13 Wk –12 Wk –10, –8, –6, –4 Wk –2 Day 1 Wk 1 Wk 2 Wk 4 Wk 6 Wk 7 Activities S1 S2 R1 R2, R3, R4, R5 R6 E1 E2 E3 E4 E5 Wk 1 Call Wk 2 Call T 1 Every 3 Mths Yearly Visits Final Treatment Visit (PD)b F1c Medical History – including questions regarding tobacco and alcohol use X Xl Xl Xl Xl Xl Complete Physical Exam X X Vital Signs (blood pressure, heart rate, weight and temperature)d X X X X X X X X X X X X X X X X Assess Limb Swellinge X X X X X X X X X X X X X X X X Blood Drawsf X X X X X X X X X X X X X X First Morning Void Urine Collectionsg X X X X X X X X (if discontinued during dosing period only) X Optional Genetic Sample X Urine Testsh X X X X X (T3 only) X X X Blood Pressure Medication Dose Adjustments X X X X
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