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Article History

Received: 23 June 2024

Accepted: 27 October 2024

First Online: 18 November 2024

Declarations

:

: The Ethics Committee of the University of Munich and Hannover Medical School (Nr. 8100_BO_S_2018) have approved analyses using the AMSP database. This study adheres to the Declaration of Helsinki and its later amendments. Due to its observational nature, AMSP does not interfere with the ongoing treatment of the patients under surveillance.

: Not applicable.

: SB, RG, and ST are project managers of the AMSP program. ST is a member of the advisory board for Otsuka and Janssen-Cilag and has received speaker´s honoraria from Janssen-Cilag, Lundbeck/Otsuka, Recordati Pharma GmbH, ROVI GmbH, and Servier. JS has participated in educational events sponsored by Otsuka/Lundbeck. AE is a member of advisory boards for Boehringer Ingelheim, Idorsia, and Recordati and has received speaker’s honoraria from Angelini, Boehringer Ingelheim, Germania, Idorsia, Janssen, Lundbeck, Mylan, Neuraxpharm, Recordati, Rovi, and Sandoz. All other authors state they have no conflicts of interest to declare. The research presented in this manuscript did not receive any specific grants or funding. The AMSP drug safety project is facilitated by non-profit associations in Germany, Austria, and Switzerland. The AMSP project has been supported with unrestricted educational and research grants since 1993 by the following companies: German companies: Abbott GmbH & Co. KG, Aristo Pharma, AstraZeneca GmbH, Aventis Pharma Deutschland GmbH GE–O/R/N, Bayer Vital GmbH, Boehringer Mannheim GmbH, Bristol-Myers-Squibb, Ciba Geigy GmbH, Desitin Arzneimittel GmbH, Duphar Pharma GmbH & Co. KG, Eisai GmbH, Esparma GmbH Arzneimittel, GlaxoSmithKline Pharma GmbH & Co. KG, Hoffmann-La Roche AG Medical Affairs, Janssen-Cilag GmbH, Janssen Research Foundation, Knoll Deutschland GmbH, Lilly Deutschland GmbH Niederlassung Bad Homburg, Lundbeck GmbH & Co. KG, Novartis Pharma GmbH, Nordmark Arzneimittel GmbH, Organon GmbH, Otsuka-Pharma Frankfurt, Pfizer GmbH, Pharmacia & Upjohn GmbH, Promonta Lundbeck Arzneimittel, Recordati Pharma GmbH, Rhone-Poulenc Rohrer, ROVI GmbH, Sanofi-Synthelabo GmbH, Sanofi-Aventis Deutschland, Schering AG, SmithKlineBeecham Pharma GmbH, Solvay Arzneimittel GmbH, Synthelabo Arzneimittel GmbH, Dr. Wilmar Schwabe GmbH & Co., Thiemann Arzneimittel GmbH, Troponwerke GmbH & Co. KG, Upjohn GmbH, Wander Pharma GmbH, and Wyeth-Pharma GmbH. Austrian companies: Astra Zeneca Österreich GmbH, Boehringer Ingelheim Austria, Bristol-Myers Squibb GmbH, CSC Pharmaceuticals GmbH, Eli Lilly GmbH, Germania Pharma GmbH, GlaxoSmithKline Pharma GmbH, Janssen-Cilag Pharma GmbH, Lundbeck GmbH, Novartis Pharma GmbH, Pfizer Med Inform, and Wyeth Lederle Pharma GmbH. Swiss companies: AHP (Schweiz) AG, AstraZeneca AG, Bristol-Myers Squibb AG, Desitin Pharma GmbH, Eli Lilly (Suisse) S.A., Essex Chemie AG, GlaxoSmithKline AG, Janssen-Cilag AG, Lundbeck (Suisse) AG, Organon AG, Pfizer AG, Pharmacia, Sanofi-Aventis (Suisse) S.A., Sanofi-Synthelabo SA, Servier SA, SmithKlineBeecham AG, Solvay Pharma AG, Wyeth AHP (Suisse) AG, and Wyeth Pharmaceuticals AG.