Haro, Josep Maria
Lamy, François-Xavier
Jönsson, Bengt
Knapp, Martin
Brignone, Mélanie
Caillou, Hugo
Chalem, Ylana
Hammer-Helmich, Lene
Rive, Benoît
Saragoussi, Delphine
Article History
Received: 15 February 2017
Accepted: 8 March 2018
First Online: 27 March 2018
Ethics approval and consent to participate
: All patients enrolled in the study provided written informed consent. Ethical approvals were obtained for each study site before study initiation. Further details of local ethics committees are given in Additional file InternalRef removed.France: French health authority (ANSM, previously called AFSSAPS), advisory committee on information processing in material research in the field of health (CCTIRS), French data protection agency (CNIL), French National Medical Council (CNOM), Ethics Committee (CPP Ile de France II); 102 physicians/sites included.Germany: Munich Ethics Committee and local ethics committees; 47 physicians/sites included.Spain: Agencia Española del Medicamento y Productos Sanitarios (AEMPS), Comités Eticos de Investigaciones Clinicas (CEIC) of nine regions, Comunidades Autónomas (CCAA) of 12 regions; 46 physicians/sites included.Sweden: Uméå Ethics Committee; 22 physicians/sites included.UK: Medical Research and Ethics Committee (MREC), National Institute for Health Research (NIHR) and local submissions; 65 physicians/sites included.
: Not applicable.
: JMH has received honoraria for participating in advisory boards for Eli Lilly and Co, Roche, Lundbeck and Otsuka. F-XL was employed by Lundbeck SAS at the time the study was conducted and the data presented in this paper were analysed. BJ has received honoraria for being an advisor to Lundbeck. MK has received consultancy funding from Lundbeck and Takeda, and has received research funding from Lundbeck. MB, BR and DS were employed by Lundbeck SAS at the time of the study concept, analysis and reporting. At the time the study was conducted and the data presented in this paper analysed HC was an employee of Inferential, a provider of biostatistical consulting services working with pharmaceutical companies including Lundbeck. YC was employed by Lundbeck SAS at time of the study concept and analysis. LH-H is a full-time employee of H. Lundbeck A/S.
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