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There are no benefits associated with participation for the individual participant, but it is considered that the risk associated with participation is low compared to the potentially valuable information obtained.The participation is strictly voluntary, participants are not paid for participation. Participants can withdraw from the study at any given time, without explanation. The nurse will obtain informed consent or assent from potential trial participants upon verbal and written information. The consent includes collection and use of participant data and storage of biologic specimens for ancillary studies.The study is conducted in accordance with the Helsinki 2 declaration and has been approved by the Danish Data Protection Agency (RH-2016-47) and the Ethical Committee (H-17024315).Collection and storage of data in the PERSIMUNE data repository has been approved by the Danish Data Protection Agency (RH-2015-04, I-Suite 03605) and the Danish National board of Health (jr.nr. 3\u20133013-1060\/1).The trial is registered at  (NCT03847285). The trial registration will be continuously updated with relevant protocol modifications if any.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"SDN: Unrestricted research grants from Novo Nordisk Foundation, Lundbeck Foundation, Augustinus Foundation, Rigshospitalet Research Council. Travelling grants from Gilead, MSD, BMS, and GSK\/ViiV. Advisory board activity for Gilead and GSK\/ViiV. SDN is also a member of BMC Infectious Diseases Editorial Board.FG: Unrestricted research grants from the Novo Nordisk Foundation, Erik and Susanne Olesens Foundation, advisory board participation Pfizer, Pharmacosmos and Bayer. Unpaid scientific advisor CARMAT, Corvia. Speakers fee Abbott, Orion, Novartis.MP: Research grants from Roche, PulmonX and BTG, Travelling grants from Novartis, Boeringer-Ingelheim, BTG, Therakos and MSD. Lecture MSD, BTG, and Novartis.CD, OR, AR, SSS, JDL, SRO: no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"573"}}