Frölich, Lutz
Wunderlich, Glen
Thamer, Claus
Roehrle, Michael
Garcia, Miguel Jr
Dubois, Bruno
Article History
Received: 25 September 2018
Accepted: 14 January 2019
First Online: 12 February 2019
Ethics approval and consent to participate
: Both studies were approved by their respective institutional review board/independent ethics committee and the competent authorities as per national and international regulations (Study 1: Medizinische Ethikkommission II der Medizinischen Fakultät Mannhein, Germany; Study 2: CPP Ile -de-France X, Hôpital Robert Ballanger, France), and conducted in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice and local legislation, as per the principles of the Declaration of Helsinki [CitationRef removed, CitationRef removed].
: Not applicable.
: LF has previously received grants from Novartis, Piramal, Merz Pharma GmbH and Janssen-Cilag GmbH and has also received personal fees from AstraZeneca, Avraham Pharma, Axon Neuroscience, Baxter, Biogen, Boehringer Ingelheim, Eisai, Eli Lilly & Co, GE Healthcare, Janssen-Cilag, Lundbeck A/S, Merck Sharp and Dohme, Novartis, Nutricia, Pfizer, Pharnext, PharmatrophiX, Piramal, Schering-Plough and Takeda. CT and MR are employees of Boehringer Ingelheim International GmbH. GW is an employee of Boehringer Ingelheim Canada Ltd. MG is an employee of Boehringer Ingelheim Pharmaceuticals Inc. BD has participated in advisory boards for Axovant, Biogen, Boehringer Ingelheim International and Lilly and has previously received grants from Merck, Pfizer and Roche.
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