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Thursday, December 07, 2006 12:46:52 AM
In the initial 80-patient randomization into four arms, only one of the arms (20 patients) is unblinded at 10 weeks. This is the arm whose initial treatment is VX-950+pegifn+ribavirin for only 12 weeks.
Two other PROVE-1 arms (40 patients combined) contain initial treatment with VX-950+pegifn+ribavirin for 24 weeks; these arms will be unblinded at 20 weeks, during 1Q07. (The only distinction between these two arms is how long the follow-up on SoC is for patients who are PCR-negative at both week 4 and week 20.)
The fourth arm in the initial 80-patient randomization is SoC only.
PROVE-1 will have a second randomization of 180 patients into each of the arms discussed above except the 12-week arm that is the one to report data this month.
Clear?
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