Received: 2 November 2017
Accepted: 4 February 2018
First Online: 26 February 2018
Ethics approval and consent to participate
: The present clinical trial is being conducted according to the ethical principles of the World Health Organization Declaration of Helsinki, national legislation of Denmark, and International Conference on Harmonization Good Clinical Practice guidelines. Permissions from the Regional Science Ethics Committee of Southern Denmark (Project ID S-20140078), the Danish Health and Medicine Agency (EudraCT 2014–001856-51), and the Danish Data Protection Agency (14/43618) have all been obtained. This study is being externally monitored by the Good Clinical Practice Unit at Odense University Hospital. Informed consent is obtained from all participants.
: Consent for publication has been obtained from all participants.
: AK is a speaker, advisory board member, and primary investigator in the PROSPER study for Norgine. All other authors declare no competing interests.
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