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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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Detalhes bibliográficos
Publicado no:Mult Scler
Main Authors: 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: Artigo
Idioma:Inglês
Publicado em: SAGE Publications 2015
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4904355/
https://ncbi.nlm.nih.gov/pubmed/26666258
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1352458515620934
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