Document is current
Any future updates will be listed below
-
Authors
-
Funding
Funding for this research was provided by:
Federal Ministry of Labour and Social Affairs (661S0183X1)
Universität zu Lübeck
- License Information
-
More Information
Article History
Received: 7 January 2022
Accepted: 10 January 2022
First Online: 15 March 2022
Declarations
:
: The investigation conforms to the principles outlined in the Declaration of Helsinki. The study protocol was approved by the Ethics Committee of the University of Lübeck (21–073), and participation in the study is voluntary. Eligible participants will receive written information on study aims, participation, and the right to refuse. Model consent and information forms are available as Additional files InternalRef removed to InternalRef removed. The study has been registered on the German Clinical Trials Register (DRKS00024648). The items from the World Health Organization Trial Registration Data Set are available as Additional file InternalRef removed. This paper contains the original study protocol. Any substantial modifications to the study protocol will be transmitted to the Ethics Committee of the University of Lübeck for approval prior to implementation. These amendments will be documented in detail in the German Clinical Trials Register and will be described transparently in trial reports.
: This manuscript does not contain any individual person’s data; hence, no consent for publication is needed.
: The authors declare that they have no competing interests.
