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Article History

Received: 22 October 2020

Accepted: 24 March 2021

First Online: 7 April 2021

Declarations

:

: The study will be carried out in accordance with the study protocol, the Helsinki Declaration, and good clinical practice. Ethics approval has been granted by the Regional Ethical Committee for the Central Denmark Region, Case # 1–10–72-68-20, 05-18-2020. Note that the ethics approval was given to two studies in one application, both taking place at the same sites during the same trial period. All participants will be given written and verbal information about the study and are free to withdraw from the study at any time for any reason. Participants who withdraw their consent for use of their data during the trial period will not be included in any of the analyses. Patients who withdraw from the study will be given the best possible TAU at the participating site.All data will be collected and stored in accordance with the European General Data Protection Regulation and the Danish legislation. The Danish Data Protection Agency has approved all data collection procedures and will monitor the data collection and storage throughout the project.

: Not applicable.

: The authors declare that they have no competing interests, financial or otherwise, in relation to this manuscript. The Danish and English versions of the manual for the ILC program are open access.