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City","Utah",{"type":35,"coordinates":152},[153,154],-111.89105,40.76078,{"lat":154,"lon":153},{"facility":19,"status":19,"city":157,"state":158,"zip":19,"country":32,"countryCode":33,"cosmosGeoPoint":159,"geoPoint":163,"contacts":19},"Norfolk","Virginia",{"type":35,"coordinates":160},[161,162],-76.28522,36.84681,{"lat":162,"lon":161},{"facility":19,"status":19,"city":165,"state":166,"zip":19,"country":32,"countryCode":33,"cosmosGeoPoint":167,"geoPoint":171,"contacts":19},"Seattle","Washington",{"type":35,"coordinates":168},[169,170],-122.33207,47.60621,{"lat":170,"lon":169},{"facility":19,"status":19,"city":173,"state":174,"zip":19,"country":32,"countryCode":33,"cosmosGeoPoint":175,"geoPoint":179,"contacts":19},"Milwaukee","Wisconsin",{"type":35,"coordinates":176},[177,178],-87.90647,43.0389,{"lat":178,"lon":177},{"facility":19,"status":19,"city":181,"state":182,"zip":19,"country":183,"countryCode":184,"cosmosGeoPoint":185,"geoPoint":189,"contacts":19},"Toronto","Ontario","Canada","CA",{"type":35,"coordinates":186},[187,188],-79.39864,43.70643,{"lat":188,"lon":187},{"type":191,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100201332","phase-3-study-of-lumacaftor-in-combination-with-ivacaftor-in-subjects-6-through-11-years-of-age-with-cystic-fibrosis-homozygous-for-the-f508del-cftr-mutation-100201332",true,"NCT01897233","Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation","A Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation","Inclusion Criteria:\n\n* Confirmed diagnosis of CF defined as: with 2 CF-causing mutations, chronic sinopulmonary disease or gastrointestinal\u002Fnutritional abnormalities\n* Subjects who weigh ≥15 kg without shoes at Screening Visit\n* Subjects who are homozygous for the F508del-CFTR mutation\n* Subjects with percent predicted forced expiratory volume in 1 second (FEV1) of 70% to 105% (inclusive) (Part A) or ≥40% (Part B) at Screening Visit where the predicted values are adjusted for age, sex, and height using the Wang equation\n* Subjects with stable CF disease and who are willing to remain on stable CF medication regimen\n* Able to swallow tablets\n\nExclusion Criteria:\n\n* History of any illness or condition that might confound the results of the study or pose an additional risk in administering study drug to the subject\n* Acute respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before Day 1 of the study\n* Abnormal liver function as defined in the protocol at Screening Visit\n* Abnormal renal function as defined in the protocol at Screening Visit\n* History of solid organ or hematological transplantation\n* Ongoing participation in an investigational drug study or prior participation in an investigational drug study within 30 days prior of Screening Visit\n* History or evidence of lens opacity or cataract at Screening Visit\n* Colonization with organisms associated with a more rapid decline in pulmonary status at Screening Visit (Part A only)\n* A standard 12-lead ECG demonstrating QTcF \\>450 msec at Screening 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