Protocol Title. A master protocol to test the impact of discontinuing chronic therapies in people with cystic fibrosis on highly effective CFTR modulator therapy (SIMPLIFY) Protocol Date: February 14, 2020 2.1 Risk / Benefit Assessment 8 3.1 Study Overview 9 4.1 Primary Objective 11 4.2 Secondary Objectives 11 4.3 Exploratory Objectives 12 5.1 Primary Endpoint 12 5.2 Secondary Endpoints 12 6.1 Study Population 13 6.2 Eligibility Criteria at Screening 13 6.3 ELIGIBILITY CRITERIA AT RANDOMIZATION (VISIT 1, DAY 0) 15 6.4 ADDITIONAL ELIGIBILITY FOR MUCUS BIOLOGY AND CLEARANCE (MCC) 15 6.5 Study Specific Tolerance for Eligibility Criteria 16 6.6 Screen Fail Criteria 16
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Sources: Protocol Agreement, Protocol Agreement, Protocol Agreement