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Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements

Despite collection of patient reported outcome (PRO) data in clinical trials of antiepileptic drugs (AEDs), PRO results are not being routinely reported on European Medicines Agency (EMA) and Food and Drug Administration (FDA) product labels. This review aimed to evaluate epilepsy-specific PRO instr...

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Autors principals: Nixon, Annabel, Kerr, Cicely, Breheny, Katie, Wild, Diane
Format: Artigo
Idioma:Inglês
Publicat: BioMed Central 2013
Matèries:
Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC3606363/
https://ncbi.nlm.nih.gov/pubmed/23497117
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1477-7525-11-38
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