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                                                                                                                                                                                                                                                                                                                18 Committee on Energy and Commerce, July 21, 2011. Medical journal editors raise significant concerns with validity of industry-funded reports. Available at: http://democrats.energycommerce.house.gov/index.php?q=news/medical-journal-editorsraise-significant-concerns-with-validity-of-industry-funded-reports/. 19 FDA, December 2008. Guidance for industry: Diabetes mellitus—evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. Available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/uc m071627.pdf/. 20 Kramer D, Xu S, Kesselheim, A, 2012. How does medical device regulation perform in the United States and the European Union? A systematic review. PLoS Med; 9(7): e1001276. 21 FDA Safety Communication. Premature Insulation Failure in Recalled Riata Implantable Cardioverter Defibrillator (ICD) Leads Manufactured by St. Jude Medical, Inc. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm314930.htm/. 22 European Medical Agency, January 2010. Guidelines on clinical investigation of medicinal products in the treatment of diabetes mellitus. CPMP/EWP/1080/00 Rev.1. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC5 00129256.pdf/. 23 Campbell D, June 2011. Pharmerging Markets: Partnering for global Health Forum. IMS Consulting Group, IMS Health. Available at: http://www.bvgh.org/LinkClick.aspx?fileticket=kMaOKGUbqgI%3D&tabid=168/. 24 BusinessWire, September 14, 2011. Over 258,000 patients recruited for cardiovascular trials between 2005-2010: companiesandmarkets.com. Available at: http://eon.businesswire.com/news/eon/20110914006526/en/cardiovasculardiseases/cardiovascular/pharmaceutical-companies/. 25 Clinicaltrials.gov, September 2012. 26 Eisenstein E, Lemons P, Tardiff B, et. al., 2005. Reducing the costs of phase III cardiovascular clinical trials. Am Heart J; 149(3): 482-488.