- Patients must consent in writing to participate in the study.
- Patients must be willing to comply with study visit schedule and study requirements,
including, for women of child-bearing potential or male patients with female partners
of child-bearing potential, the use of 2 forms of birth control, one of which is a
- Patients must have participated in the A4091026 study.
- Withdrawn from the A4091026 study for an adverse event or serious adverse event.
- Pregnant women, lactating mothers, women suspected of being pregnant, and women who
wish to be pregnant during the course of clinical 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 patient
inappropriate for entry into this study.