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The statistical analysis of a clinical trial when a protocol amendment changed the inclusion criteria

BACKGROUND: Sometimes, protocol amendments that change the inclusion and exclusion criteria are required in clinical trials. Then, the patient populations before and after the amendment may differ. METHODS: We propose to perform separate statistical tests for the different phases, i.e. for the patie...

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Detalles Bibliográficos
Autores principales:	Lösch, Christian, Neuhäuser, Markus
Formato:	Texto
Lenguaje:	English
Publicado:	BioMed Central 2008
Materias:	Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2359757/ https://www.ncbi.nlm.nih.gov/pubmed/18397525 http://dx.doi.org/10.1186/1471-2288-8-16

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