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DESIGN AND POWERING OF CYSTIC FIBROSIS CLINICAL TRIALS USING RATE OF FEV(1) DECLINE AS AN EFFICACY ENDPOINT

BACKGROUND: Rate of lung function decline (RLFD) (as FEV(1) percent predicted/yr) is a robust measure of CF therapeutic efficacy rarely used as a study endpoint, in part due to uncertainty of sample size requirements. METHODS: Sample size requirements for 1:1 randomizations to detect RLFD treatment...

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Detalhes bibliográficos
Main Authors: Konstan, MW, Wagener, JS, Yegin, A, Millar, SJ, Pasta, DJ, VanDevanter, DR
Formato: Artigo
Idioma:Inglês
Publicado em: 2010
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4079112/
https://ncbi.nlm.nih.gov/pubmed/20646968
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.jcf.2010.05.004
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