- Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12
week) induction period.
- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
- Women of childbearing potential, who have sexual intercourse with a non surgically
sterilized male partner, must agree and commit to the use highly effective methods of
birth control from signing of the ICD through 26 weeks after the Final Study
Evaluation or for 62 weeks from the last dose of investigational product for any
subject who terminates early from this study.
- Subjects that have completed Day 84 (Week 12) of study B0151003, and experienced
serious event(s) related to the investigational product, an unstable medical
condition, or any other reason, in the opinion of the investigator, would preclude
entry or inclusion in this study.
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate entry into this study.
- Received any prohibited treatment during study B0151003 that, in the opinion of the
investigator, compromised the safety or efficacy of this study.