Wednesday, August 31, 2016 8:57:40 AM
It will *probably* be somewhere in the range of 5% - 10% (standard dev), or somewhere around 400 to 800 subjects. Sometimes it can get pretty high, though, even when the intervention is well tolerated. For example:
Btw that high dropout rate led to a CRL.
I just thought of another thing:
How easy is it to "open" one of your pills and spill the contents into a cup and let it ferment? Smells fishy = Vascepa, smells non fishy = mineral oil. Curiosity must get the best of many, esp when their heart-health is on the line. And we are talking upwards of 6 years of daily dosing, twice a day, for these subjects. That's a lot of pills to not know what's in them. And too many ways to find out what's in said pills.
I'm sure you could also just take some mineral oil, some high EPA only bottle of OTC pills, and conduct a few simple experiments to compare these oils with what's in the pills you get on study and find out exactly what's in your study "drug." How viscous is it? How does it feels between your fingers? Smell? Taste? And of course, which goes rancid in a week in open air and which does not? How do they respond to heat differently?
Oy
GL
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