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Re: meirluc post# 217550

Monday, 03/11/2019 3:27:03 AM

Monday, March 11, 2019 3:27:03 AM

Post# of 690746
I think LG was correct to imply these 31 patients were randomized appropriately. Maybe the "missing" 17 to fully enroll 348 were also randomized appropriately but were excluded from entering the trial.

If you look at the trial's enrollment curve, it shows 331 enrolled by Nov 2015, just 3 months after the partial clinical hold. It's possible the final 48 were ready to complete enrollment by Nov 2015 but the 17 randomized to placebo were excluded.

So the randomization was done on the last 48 but the 31 randomized to treatment were entered into the trial and the 17 randomized to placebo were excluded.

This is JMO and a WAG.
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