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CalMustang

08/08/19 12:35 PM

#206594 RE: KCSVEN #206582

Label will have statins since that was RI population but for Amarin to run a study without statins would have been almost impossible.



Why? It looks like Mochida is doing it in Japan: https://clinicaltrials.gov/ct2/show/NCT03693131

Inclusion Criteria:

1. Participants diagnosed with hypertriglyceridemia.
2. Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL.