Thanks to both for their replies.
Regarding the "CV risk Categories 1 and 2" from the protocol, and using the definitions I previously posted (secondary prevention patients are only those who have experienced a MACE event), if I am reading the categories correctly,
Category 1 would necessarily include secondary prevention patients (those who have experienced a MACE event) and it would also include some primary prevention patients (those who have not experienced a MACE event, but who otherwise fit the Cat 1 criteria, e.g., documented multi-vessel CAD, asymptomatic carotid artery disease with > 70% stenosis, documented PAD.
Category 2 would consist of 50 y/o diabetics with at least one additional risk factor.
So, I believe these two categories don't line up with my definition of Primary and Secondary Prevention.
Further, and importantly, there are a lot of patients who are at elevated risk for MACE and who would fall into my definition of Primary Prevention. An example would include a 45 y/o male with LDLc controlled by statin, with Trigs = 140, no history of MACE, no diabetes, no obesity, no smoking hx, no family hx of MACE, but a calcium score of 25 (which establishes a Dx of CVD). Further you could add in any (or all) of a number of risk factors, such as higher age, obesity, smoking, higher trigs, +family hx of MACE, and higher calcium score, and still the person would be in my definition of primary prevention, but not in Category 2 (or 1).
Thus, I'm still unsure Amarin, presenters, FDA and panelists, were using the terms Primary prevention and Secondary prevention uniformly.
