Yahyavi, Sam Kafai https://orcid.org/0000-0002-6658-5094
Holt, Rune
Juel Mortensen, Li
Petersen, Jørgen Holm
Jørgensen, Niels
Juul, Anders
Blomberg Jensen, Martin
Funding for this research was provided by:
XY Therapeutics
Article History
Received: 31 January 2022
Accepted: 11 June 2022
First Online: 22 June 2022
Declarations
:
: The study will be carried out to include the protection of human subjects according to the 2008 Declaration of Helsinki and following Good Clinical Practice Guidelines. After verbal and written information is given to potential participants, informed consent will be obtained. All risk or safety issues will be reported to the principal investigators, who will take any necessary further steps. The study has been approved by the National Ethics Committees of the capital region of Denmark (H-21040145) and the Danish Medicines Agency (EudraCT no: 2021–003451-42) which qualified for registration in the ClinicalTrials.gov database (identifier NCT05212337). Major modifications, such as changes to outcome measures or change of design, will be sent to and evaluated by the National Ethics Committees of the capital region of Denmark, Good Clinical Practice unit, and Danish Medicines Agency.
: Not applicable.
: The authors declare that they have no competing interests except that Martin Blomberg Jensen also is the CEO of “XY Therapeutics.”