Funding for this research was provided by:
Lundbeck GmbH and Otsuka Pharma GmbH
Received: 19 September 2022
Accepted: 3 March 2023
First Online: 14 March 2023
: The German 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 (23), 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). For the Canadian study, all patients signed an informed consent form before any study related procedures were performed. Central ethics approval was obtained from IRB Services, Aurora, Ontario, Canada. In addition, approval from local institutional ethics boards (University of Windsor, McGill University Health Centre, Institut Universitaire en Santé Mentale de Québec, Capital Health, Ottawa Health Science Network, Royal Ottawa Health Care Group, University of Calgary, Western University, Queen’s University, Douglas Mental Health University Institute, University of British Columbia) was obtained as required. All methods were carried out in accordance with the Declaration of Helsinki.
: Not applicable.
: DS received honoraria for lectures from or has been an advisor to Janssen GmbH, Lundbeck GmbH, Otsuka Pharma GmbH, Rovi and Takeda.WJ is an employee of Lundbeck GmbH.FT is an employee of Otsuka Canada Pharmaceutical Inc.KW received honoraria for lectures and advisory board participation from Janssen-Cilag GmbH, Lundbeck GmbH and Otsuka GmbH.