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Responders vs clinical response: a critical analysis of data from linaclotide phase 3 clinical trials in IBS-C
BACKGROUND: US Food and Drug Administration (FDA) set a rigorous standard for defining patient responders in irritable bowel syndrome-C (IBS-C; i.e., FDA's Responder Endpoint) for regulatory approval. However, this endpoint's utility for health-care practitioners to assess clinical respons...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BlackWell Publishing Ltd
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4282394/ https://www.ncbi.nlm.nih.gov/pubmed/24382134 http://dx.doi.org/10.1111/nmo.12264 |