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Authors
Dunvald, Ann-Cathrine Dalgård https://orcid.org/0000-0001-7574-0909
Søltoft, Kasper https://orcid.org/0000-0002-1111-8050
Sheetal, Ekta
Just, Søren Andreas https://orcid.org/0000-0002-3946-5919
Frederiksen, Ida Emilie Brejning
Nielsen, Flemming https://orcid.org/0000-0002-5657-405X
Olsen, Dorte Aalund https://orcid.org/0000-0003-2589-738X
Madsen, Jonna Skov https://orcid.org/0000-0001-6668-4714
Hendricks, Oliver https://orcid.org/0000-0001-9473-5072
Stage, Tore Bjerregaard https://orcid.org/0000-0002-4698-4389
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Funding
Funding for this research was provided by:
Lundbeckfonden (R307-2018-2980)
University Library of Southern Denmark
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Article History
Received: 17 June 2023
Accepted: 22 September 2023
First Online: 13 October 2023
Declarations
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: The studies were conducted in accordance with the Helsinki Declaration. The prospective clinical pharmacokinetic trial was approved by the Regional Scientific Ethics Committee of Southern Denmark (identifier S-20210010), the Danish Medicines Agency (identifier 2021013658), and registered in the EudraCT database (identifier 2020–005998-27) and the ClinicalTrials.gov database (identifier NCT04842981). The study complied with Good Clinical Practice (GCP) and was monitored by the GCP unit at Odense University Hospital. Trial subjects were included following written, informed consent. The retrospective study was approved by the Regional Ethics Committee of Southern Denmark (identifier S-20210097). Patients gave written informed consent for the biological material and personal information to be stored and used for future unspecified research when the biobank samples were collected.
: A.C.D. has given paid lectures for Astellas Pharma. T.S. has given paid lectures for Pfizer and Eisai and consulted for Pfizer. All are unrelated to the work reported in this paper. K.S., E.S., S.A.J., I.E.B.F., F.N., D.A.O., J.S.M., and O.H. report no conflicts of interest.
