Document is current

Article History

Received: 16 March 2022

Accepted: 3 January 2023

First Online: 28 January 2023

Declarations

:

: The trial was carried out in compliance with the approved clinical trial protocol, which was in accordance with the principles of the Declaration of Helsinki, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines, applicable regulatory requirements, and Boehringer Ingelheim standard operating procedures. All participants provided informed written consent in accordance with the ICH GCP and local legislation. All patients had to be able to give informed consent personally and have the capacity for such consent. Each patient also had to have a trial partner who was required to consent separately. The study protocol was reviewed and approved by the local independent ethics committees and relevant local authorities.

: Not applicable.

: GW, ZB, and MG are full-time employees of Boehringer Ingelheim. GW and ZB have received financial support for travel from Boehringer Ingelheim. FJ is an employee of Klinik und Poliklinik für Psychiatrie und Psychotherapie and has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Danone, Eisai, GE Healthcare, Green Valley, Hummingbird Bioscience, MSD, OM Pharma, Vifor Pharma, Roche, and Janssen. In addition, FJ has received payment for presentations and advisory boards from AC Immune, Eli Lilly, Janssen, and Roche; has performed contracted research for Boehringer Ingelheim; and is on the executive board of the German Psychiatric Association (DGPPN) and the European Alzheimer’s Disease Consortium (EADC). Medical writing support was provided by Lisa Auker, PhD, and Lesley Blogg, PhD, of Fishawack Communications Ltd., part of Fishawack Health, and was funded by Boehringer Ingelheim GmbH.