Ethics statement
ICH
The study was performed in accordance with the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline and Good Clinical Practice (ICH E6(R2)-GCP) ethical principles that have their origin in the Declaration of Helsinki, and applicable regulatory requirements. The protocol, amendments, informed consent forms, and translations were approved by Schulman central institutional review board (Cincinnati, Ohio, USA) prior to commencement of the study. Written informed consent was obtained from all participants prior to enrollment. The study protocol and the statistical analysis plan are available online at ClinicalTrials.gov where the study was registered (NCT03342898).