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Le nombre de patients pour lesquels le score du domaine IIEF s'est normalise (>26) etait de 53% avec le vardenafil comparativement a 9% avec le placebo. Les taux de reponse concernant l'obtention et le maintien de l'erection ont ete de 76% et 59% avec le vardenafil comparativement a 41% et 22% avec le placebo, chez les patients parvenus au terme des trois mois de traitement. Ces differences etaient cliniquement et statistiquement significatives (p. La tolerance et l'efficacite du vardenafil se maintenaient dans les etudes a long terme. L’Agence europeenne des medicaments a accorde une derogation a l’obligation de soumettre les resultats d’etudes realisees dans tous les sous-groupes de la population pediatrique dans le traitement de la dysfonction erectile (voir rubrique Posologie et mode d'administration pour les informations concernant l’usage pediatrique). 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