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Placebo-controlled study in neuromyelitis optica—Ethical and design considerations

BACKGROUND: To date, no treatment for neuromyelitis optica (NMO) has been granted regulatory approval, and no controlled clinical studies have been reported. OBJECTIVE: To design a placebo-controlled study in NMO that appropriately balances patient safety and clinical–scientific integrity. METHODS:...

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Detalles Bibliográficos
Autores principales: Cree, Bruce AC, Bennett, Jeffrey L, Sheehan, Mark, Cohen, Jeffrey, Hartung, Hans-Peter, Aktas, Orhan, Kim, Ho Jin, Paul, Friedemann, Pittock, Sean, Weinshenker, Brian, Wingerchuk, Dean, Fujihara, Kazuo, Cutter, Gary, Patra, Kaushik, Flor, Armando, Barron, Gerard, Madani, Soraya, Ratchford, John N, Katz, Eliezer
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4904355/
https://www.ncbi.nlm.nih.gov/pubmed/26666258
http://dx.doi.org/10.1177/1352458515620934