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Re: rafunrafun post# 90641

Wednesday, 08/31/2016 8:57:40 AM

Wednesday, August 31, 2016 8:57:40 AM

Post# of 424139
Lol, okay I'll amend my statement: it is extremely unlikely that the number of dropouts (withdrew consent + violated protocol + LTFU) in R-IT is only 175n.

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:

In the ATLAS ACS 2–TIMI 51 trial, 2,402 patients (15.5%) prematurely discontinued from the study, with 1,294 patients (8.3%) withdrawing consent. At the end of the trial, vital status was not ascertained in 1,117 of the 1,294 patients who withdrew consent.



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

"Think for yourselves and let others enjoy the privilege to do so, too."

-Voltaire

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