Ethics approval and consent to participate
The study protocol was approved by the Regional Scientific Ethics Committee (H-15009313), the Danish Data Protection Agency (2012–58-0004), participants supplied written and verbal informed consent, and the study was completed in accordance with the Declaration of Helsinki. The trial was conducted and monitored by an independent unit from Copenhagen, Denmark, in accordance with the International Conference on Harmonization Guidelines for Good Clinical Practice. The trial was registered at the European Clinical Trials Register (Date of registration: 25/08/2015, EudraCT number: 2015–002519-14). Due to an inability of performing NMR-imaging on the required patients needed to adhere to the initial power calculation of the primary endpoint, liver fat, an amendment was added to the protocol allowing the inclusion of an additional 10 patients. The amendment was not influenced by conditions concerning the reported endpoints in the present manuscript.