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English to Spanish: Ensayos clínicos General field: Science Detailed field: Medical: Pharmaceuticals
Source text - English This is a randomized, subject- and investigator-blinded, placebo-controlled, parallel-group study investigating the preliminary efficacy and safety of xxxxxx administered orally for 12 weeks in subjects with bronchiectasis.
Approximately 72 subjects will be randomized in a 1:1 ratio to receive either xxxxxx or placebo in order to achieve 60 subjects who complete the treatment period based on the assumption of a 16% drop-out rate. The sample size assumptions will be reviewed in an interim analysis in a blinded manner when approximately 14 subjects complete the treatment period.
The study consists of the following periods: Screening, baseline/Day 1, treatment period, and end of study assessments (EOS) visit followed by an additional post-treatment safety follow up via phone call. The total duration for each subject in the study is up to approximately 18 weeks.
Translation - Spanish Se trata de un estudio aleatorizado, ciego para el sujeto y para el investigador, controlado con placebo y de grupos paralelos que investiga la eficacia y la seguridad preliminares de xxxxxx administrado por vía oral durante 12 semanas en sujetos con bronquiectasia. Aproximadamente, se aleatorizará a 72 sujetos en una proporción de 1:1 para recibir xxxxxx o bien placebo, con el fin de alcanzar 60 sujetos que completen el período de tratamiento en función de una supuesta tasa de abandono del 16 %. Los supuestos del tamaño de la muestra se revisarán en un análisis intermedio de forma ciega cuando aproximadamente 14 sujetos completen el período de tratamiento. Selección, inicio del estudio/día 1, período de tratamiento y visitas de las evaluaciones del final del estudio (FdE) a los que les sigue también un seguimiento de la seguridad telefónico posterior al tratamiento. La duración total para cada sujeto del estudio es de un máximo de 18 semanas aproximadamente.
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Graduate diploma - Universidad Pablo de Olavide
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Years of experience: 17. Registered at ProZ.com: Nov 2010.
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