Funding for this research was provided by:
Lundbeck GmbH and Otsuka GmbH
Text and Data Mining valid from 2020-02-22
Received: 31 May 2019
Accepted: 10 February 2020
First Online: 22 February 2020
Ethics approval and consent to participate
: This study was approved by the Freiburg ethics commission international (Approval number: 014/1336). All patients gave written informed consent. Planning, conduct, and evaluation of the NIS was based on legal requirements of the German Medical Products Act (Gesetz über den Verkehr mit Arzneimitteln, §4 [CitationRef removed], sentence 3), the relevant recommendations of the Federal Institute for Drugs and Medical Devices (BfArM), and the Paul-Ehrlich Institute (Empfehlungen des Bundesinstituts für Arzneimittel und Medizinprodukte und des Paul-Ehrlich- Instituts zur Planung, Durchführung und Auswertung von Anwendungsbeobachtungen 2010) as well as the guidelines of the FSA code (Freiwillige Selbstkontrolle für die Arzneimittelindustrie e. V. 2015).
: Not applicable.
: DS received honoraria for lectures from or has been an advisor to Janssen GmbH, Lundbeck GmbH, Otsuka Pharma GmbH and Takeda. WJ is an employee of Lundbeck GmbH. DL and EB reported no conflicts of interest. CC has been a consultant and/or advisor to or has received honoraria from: Alkermes, Allergan, Gerson Lehrman Group, IntraCellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, Medavante, Medscape, Neurocrine, Otsuka, Pfizer, ROVI, Sunovion, Takeda, and Teva. He has provided expert testimony for Bristol-Myers Squibb, Janssen, and Otsuka. He served on a Data Safety Monitoring Board for Lundbeck, Pfizer, Roche, and ROVI. He received royalties from UpToDate and grant support from Janssen, Neurocrine and Takeda. He is also a shareholder of LB Pharma. KW has been a consultant and received honoraria for lectures from Janssen GmbH, Lundbeck GmbH and Otsuka Pharma GmbH.