Measuring HDL/LDL for a CETP inhibitor is not useful for determining power and setting up trial design, which is the whole point of a Phase II program. Morbidity and mortality are the proper endpoints.
I'm with PGS on this one. You are asking for the (by far) largest, longest and most expensive Phase II ever. 20,000 patient-years maybe? (And more if you have multiple doses).
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