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Long-term safety of lumacaftor-ivacaftor in children aged 2-5 years with cystic fibrosis homozygous for the F508del-CFTR mutation: a multicentre, phase 3, open-label, extension study.
Lancet Respir Med. 2021 Sep;9(9):977-988. doi: 10.1016/S2213-2600(21)00069-2. Epub 2021 May 6.
Lancet Respir Med. 2021.
PMID: 33965000
A Phase 3, Open-Label Study of Lumacaftor/Ivacaftor in Children 1 to Less Than 2 Years of Age with Cystic Fibrosis Homozygous for F508del-CFTR.
Rayment JH, Asfour F, Rosenfeld M, Higgins M, Liu L, Mascia M, Paz-Diaz H, Tian S, Zahigian R, McColley SA.
Rayment JH, et al. Among authors: zahigian r.
Am J Respir Crit Care Med. 2022 Nov 15;206(10):1239-1247. doi: 10.1164/rccm.202204-0734OC.
Am J Respir Crit Care Med. 2022.
PMID: 35771568
Free PMC article.
Clinical Trial.
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Two-stage adaptive enrichment design for testing an active factor.
Ding AA, Wu SS, Dean NE, Zahigian RS.
Ding AA, et al. Among authors: zahigian rs.
J Biopharm Stat. 2020;30(1):18-30. doi: 10.1080/10543406.2019.1609015. Epub 2019 May 28.
J Biopharm Stat. 2020.
PMID: 31135263
Free PMC article.
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