title: [Not Available].
authors.affiliation: Laboratoire Boehringer Ingelheim, Reims, France.. Electronic address: pascal.bilbault@boehringer-ingelheim.com.
authors.forename: Pascal
authors.initials: P
authors.lastname: Bilbault
authors.affiliation: Afssaps, Saint-Denis, France.
authors.forename: Chantal
authors.initials: C
authors.lastname: Belorgey
authors.affiliation: Centre d'Investigation Clinique, Hôpital Jeanne d'Arc, Dommartin les Toul, France.
authors.forename: Faiez
authors.initials: F
authors.lastname: Zannad
authors.affiliation: Direction Générale de la Santé, Paris, France.
authors.forename: Danielle
authors.initials: D
authors.lastname: Golinelli
authors.affiliation: Laboratoire Pfizer, Paris, France.
authors.forename: Yannick
authors.initials: Y
authors.lastname: Pletan
keywords: directive européenne; essais cliniques; recherche biomédicale; risque; révision