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Central adjudication of serious adverse events did not affect trial’s safety results: Data from the Efficacy of Nitric Oxide in Stroke (ENOS) trial
BACKGROUND AND PURPOSE: Central adjudication of serious adverse events (SAEs) can be undertaken in clinical trials, especially for open-label studies where outcome assessment may be at risk of bias. This study explored the effect of central adjudication of SAEs on the safety results of the Efficacy...
Autores principales: | Godolphin, Peter J., Montgomery, Alan A., Woodhouse, Lisa J., Bereczki, Daniel, Berge, Eivind, Collins, Rónán, Díez-Tejedor, Exuperio, Gommans, John, Lees, Kennedy R., Ozturk, Serefnur, Phillips, Stephen, Pocock, Stuart, Prasad, Kameshwar, Szatmari, Szabolcs, Wang, Yongjun, Bath, Philip M., Sprigg, Nikola |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6258247/ https://www.ncbi.nlm.nih.gov/pubmed/30475912 http://dx.doi.org/10.1371/journal.pone.0208142 |
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