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Thursday, October 13, 2011 12:58:42 PM
What exactly would a "stoppage for efficacy" mean now in the context of the HEAT trial?
Everyone has been enrolled (600). They get a one-time (or in some cases, two-time) RFA + placebo or ThermoDox treatment, and then they're just monitored going forward.
If the treatments are all completed, then what does a "stoppage" really mean? They're not going to go back and re-ablate all the placebos, are they?
I wonder if this has an impact on the DMC's attitude about a stoppage, considering nothing ethical is at stake.
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