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Funding: The trial was funded as an investigator-initiated research grant by TJA Health, LLC, in Joliet, Ill. to the University of Illinois, College of Dentistry with KF as Principal Investigator and CAE as Co-Principal Investigator. The funding source had no role in the design, conduct, analysis, interpretation, preparation of the manuscript, or in the decision where to submit.
Conflict of Interest: KF, CAE, LB, LG, BZB, and PM reported no disclosures. SH reported owning publicly traded shares of Cardiovascular Systems Inc, a cardiovascular instrument development business for commercializing innovative solutions for treating peripheral and coronary vascular disease. The total value current value is <$5000. DLD reported that he is a consultant to the National Institutes of Health, the Food and Drug Administration, and the pharmaceutical and medical device industry on the design, monitoring, and analysis of clinical trials. He receives compensation for serving on several industry sponsored data and safety monitoring committees including Astra Zeneca, Amgen, Actelion, GlaxoSmithKline, Merck, Sanofi, Boehringer Ingelheim, Teva, and Abbvie. He holds no stock in any pharmaceutical or device company. CHH reported that he is funded by the Charles E. Schmidt College of Medicine at Florida Atlantic University; serves as an independent scientist in an advisory role to investigators and sponsors as: Chair or Member of Data and Safety Monitoring Boards for Amgen, AstraZeneca, Bayer, Bristol Myers-Squibb, British Heart Foundation, Cadila, Canadian Institutes of Health Research, DalCor, Genzyme, Lilly, Regeneron, Sanofi, Sunovion, and the Wellcome Foundation; to Aralez/Pozen, the US Food and Drug Administration, UpToDate, and to Pfizer and their legal counsel; receives royalties for authorship or editorship of 3 textbooks and as co-inventor on patents for inflammatory markers and cardiovascular disease that are held by Brigham and Women's Hospital; has an investment management relationship with the West-Bacon Group within SunTrust Investment Services, which has discretionary investment authority and does not own any common or preferred stock in any pharmaceutical or medical device company.
Authorship: All authors had access to the data and a role in writing the manuscript.