(a).
Prednisone dispensed at visit | When medication dispensed should be used by patient | |||||||||||
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Visit name |
(Additional prednisone may be dispensed at some study visits to allow for the maximum study visit window and duration between study visits) |
IxRS reference | eCRF reference | Patient diary reference | Prednisone |
Prednisone taken by patient at corresponding patient diary study week number |
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Type | Comments | Visit folder | Study week number | Study week number | Wallet number∗ (taper week)∗ blinded part only | Type | Number per day | Number of tablets remaining | Medication returned at end of 7 days | |||
Baseline | 1 open label 10 mg bottle containing 100 tablets | Baseline to study week 1 | Baseline | 0 | 0 | 1 | Open-label taper 60 mg/d | 6 tablets per day | 58 tablets remaining | No continue to use tablets in study week 1 | ||
Study week 1 to study week 2 | Week 1 | 1 | 1 | 2 | Open-label taper 50 mg/d | 5 tablets per day | 23 tablets remaining | Yes return at study week 2 visit | ||||
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Study week 1 | 1 open label 10 mg bottle containing 100 tablets | Study week 2 to study week 3 | Week 2 | 2 | 2 | 3 | Open-label taper 40 mg/d | 4 tablets per day | 72 tablets remaining | Yes return at study week 3 visit | ||
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Study week 2 | 2 open label 5 mg wallet (wallet contains 40 capsules) | Study week 3 to study week 4 | Week 3 | 3 | 3 | 4 | Open-label taper 35 mg/d | 7 capsules per day | 31 capsules remaining | No continue to use capsules in study week 4 |