Document is current

Article History

Received: 6 May 2021

Accepted: 27 October 2021

First Online: 22 November 2021

Declarations

:

: Ethical approval from all of the participating study sites have been obtained. The study is approved by the Institutional Review Board of the Medical Faculty of the Technical University Dresden (ID: SR-EK-57012021, date: 3 March 2021). In addition, further approval have been received by the Ethics Committee of the State Chamber of Commerce of Baden-Württemberg (B-F-2021-040_2021-04-19), the Ethics Committee at the Medical Faculty of the Eberhard-Karls-Universität and at the University Hospital Tübingen (381/2021BO2) and a fourth ethics committee (name and ID can, due to data protection reason, only be received upon request). All participants and their custodians in Module B and all family members in Module C will give written informed consent before entering the study. Data will be handled, analyzed and reported according to Good Epidemiological Practice (GEP) [CitationRef removed], Good Practice of Secondary Data Analysis (GPS) [CitationRef removed], a Consensus German Reporting Standard for Secondary Data Analyses, Version 2 (STROSA 2) [CitationRef removed] and German Recommendations on Health Economic Evaluation (Hanover Consensus) [CitationRef removed].

: Not applicable.

: The authors have no competing interests to declare/Not Applicable.