Document is current

Article History

Received: 3 May 2023

Accepted: 16 May 2023

First Online: 7 June 2023

Declarations

:

: Ethics approval—including approval for all experimental protocols—has been obtained from Charité – Universitätsmedizin Berlin (EA4/062/22). The proposed study does not involve any psychological or medical treatments or any psychologically or medically invasive experiments. All participants will receive oral and written information about the study procedures. They will be informed about their right to withdraw from the study at any time without giving a reason. All participants will sign informed consent forms before participating in the study. Participants will be debriefed after the laboratory study. All methods will be carried out in accordance with relevant guidelines and regulations (Declaration of Helsinki).

: Not applicable.

: The authors have no relevant financial or non-financial competing interests to report. SR reports personal fees from Janssen, Otsuka, Bionorica SE, Boehringer Ingelheim, and Stillachhaus outside the submitted work and reports grants from the German Research Foundation (DFG), German Ministry of Education and Research (BMBF), and Innovationsfond. The submitted work was not influenced by these fees and grants, either directly or indirectly.

: At baseline, each participant will be assigned an ID, and the same ID will be used throughout the study for all measures. All study computers will be password-protected and kept in locked offices. We will maintain a secure, password-protected study server for data storage. Our local computer networks are secured by mandatory log-in to individual password-protected accounts and will be audited daily for unauthorized access. Monthly backup tapes will be kept in locked, offsite safe deposit boxes. Data with identifiers, such as names or addresses, will be separated from the study data and kept only at the clinical sites and will be password protected. All data analyses will be performed without patient identifiers. All data and procedures will be archived for at least 10 years after publication.

: Patient partners and advocates have not been formally involved in the design of this study. All questions and procedures were designed with the priorities, experiences, and preferences of patients in mind.