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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:...
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 |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2015
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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 |
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