Institutional Review Board Statement
RECRUITMENT
The study was conducted in accordance with the Declaration of Helsinki and approved by The Regional Ethical Review Board, Gothenburg, Sweden (DNR 663-17, approved: 14 December 2017), the institutional review board of Federico II University (n. 175/17, approved: 25 October 2017), and the biomedical institutional review board at Perdue University (n. 1610018310, approved: 9 January 2018). The trial was registered in the public trial registry clinicaltrials.gov as NCT03410719 prior to initiating participant recruitment.