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JAMA Cardiol 2(12):13151321 Arnold SV, Stone GW, Mack MJ, Chhatriwalla AK, Austin BA, Zhang Z et al (2020) Health status changes and outcomes in patients with heart failure and mitral regurgitation: COAPT Trial

The Orange Book also does not capture continuation patents, method-of-use patents tied to specific indications, or patents that are filed but not yet granted at the time an ANDA is submitted