Funding for this research was provided by:
Innovationsfond/GBA Germany (01 VSF17027)
Received: 8 January 2021
Accepted: 9 February 2021
First Online: 27 February 2021
Ethics approval and consent to participate
: The Ethics Committee of the Medical Faculty of the University of Leipzig (413/18-lk), as well as the Ethics Committee of the International Psychoanalytic University Berlin (2018–18 SKKIPPI 2), and the Ethics Committee of the Hamburg Medical Association (MC-134/19), have given their approval. Data will be assessed, processed and stored according to the data protection laws and the local data protection protocol. The research project will be carried out in compliance with the study protocol and the Declaration of Helsinki (1996 version, Somerset West). All researchers and participants in the study are obliged to follow the rules of Good Clinical Practice (ICH-GCP). The study is designed as an open, randomised controlled trial with blinded endpoint assessment and blinded analysis. Nevertheless, participants are aware of their treatment group allocation.Written informed consent will be obtained from all participants and legal guardians. Participants will be enrolled in the study only after they have given informed consent. Participants can withdraw their consent at any time, without affecting their treatment.In case of revocation, no further data of the patient will be collected. The data already collected may be used for data evaluation. Only the participating study centres will have access to the anonymised data, and participants will be asked for permission to share anonymised data for future research upon reasonable request. There is no anticipated harm for trial participation, and there will be no provision for post-trial care. This trial does not involve collecting biological specimens for storage.Any modifications to the protocol that may impact the conduct of the study, a potential benefit of the patient or may affect patient safety, including changes of study objectives, study design, patient population, sample sizes, study procedures, or significant administrative aspects, will require a formal amendment to the protocol. Such an amendment needs to be agreed upon by the SKKIPPI consortium and approved by the Local Ethics Committee. The project leader will inform the sponsor and update the protocol in the clinical trial registry. Any deviations from the protocol will be fully documented using an electronic Case Report Form (eCRF).
: Not applicable.
: The authors declare that they have no competing interests.