KNJS There was IMHO 2 aims in MITIGATE First aim was as U state the results on Covid The second aim IMHO was to increase the level of evidence on CV outcomes ...this was the secondary Outcomes part of the trial . Why was this important. The Vazkepa level of evidence in the EU is 2a or 2b . While the UK may accept this level of evidence for reimbursement ( see previous post to Zip ) , Germany and France usually want higher levels of evidence...preferably level 1 which requires at least 2 double blinded placebo controlled clinical trials.
Currently AMRN only has R-IT that qualifies for Germany's level 1 rating . CV data from MITIGATE could have been used to increase the level of evidence rating for Germany and France since altho it was sponsored by AMRN, it was run and completely controlled by Kaiser in a diversified US population of high risk secondary prevention patients. JMO Kiwi
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