Funding for this research was provided by:
Deutsche Forschungsgemeinschaft (389891681)
Instituto de Salud Carlos III (CP II 17/00029)
Novo Nordisk (Investigator-initiated study Grant)
Text and Data Mining valid from 2019-10-31
Received: 4 September 2019
Accepted: 11 October 2019
First Online: 31 October 2019
Ethics approval and consent to participate
: The study was performed in Beth Israel Deaconess Medical Center (BIDMC) MA, USA, with prior approval of Institutional Review Board (IRB) from 2016 until 2018. The study followed the Consolidated Standards of Reporting (CONSORT) guidelines and the International Conference on Harmonization for Good Clinical Practice [CitationRef removed] (Additional file InternalRef removed: Consort Flow Diagram).IRB of BIDMC reviewed and approved advertisement and fliers prior to use, as well as the informed consent forms. Personal information was collected according to the standardized ethics rules. After explaining the purpose and the procedures of the study and risks and benefits, a written informed consent was obtained for participation in this randomized, placebo-controlled, cross-over, double-blind study.
: All authors have seen and read the material to be published and give the consent for publication to the Cardiovascular Diabetology.
: CSM has received consulting fees, an investigator-initiated study grant from Novo Nordisk and research support through his institution, BIDMC, for investigator-initiated research. CSM is an advisor of Ansh Labs LLC. Other authors have no competing interests to declare.