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Enrollment change, Trial termination, Trial primary completion date, Surgery: A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study (clinicaltrials.gov) - Jan 28, 2015 P2, N=10, Terminated, N=103 --> 10 | Recruiting --> Terminated | Trial primary completion date: Oct 2015 --> Dec 2014; B5301001 study did not meet its predefined efficacy endpoints, the long term follow up study B5301012 was terminated in 1/6/2015. No safety concerns identified.
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