At each visit, participants will undergo a physical examination, a spirometry test as appropriate , a respiratory specimen for Pseudomonas aeruginosa Pa culture will be collected and study drug will be dispensed except at Week Participants will complete self-report or parent-completed respiratory symptom questionnaires and signs and symptoms evaluations will be performed at all visits. Repeat hearing and laboratory tests will be performed at Weeks 39 and 78 and ECG testing will be repeated at Day 21 and Week Participants will be required to maintain a medication diary throughout the study.
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