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The FDA based its decision on two Phase 3 clinical trials, CORALreef Lipids and CORALreef HeFH

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A further longitudinal study estimated an incidence rate of 68 cases per 1000 person-years over 2.8 years, with higher risk observed among older patients, those with type 2 DM, and patients with autonomic and sensory neuropathy [14]

[DOI] [PubMed] [Google Scholar] 20.Wainwright MS, Kohli R, Whitington PF, Chace DH
