- Male or female subjects 45 to 70 years of age
- Within 96 hours prior to dosing, the subject underwent a successful open wedge tibial
osteotomy to correct medial compartment OA of the knee.
- Female subjects of childbearing potential must have a negative pregnancy test
(hospital acceptable test), upon hospitalization for OWO and agree to use medically
approved contraception for the duration of the study.
Other inclusion applies.
- Subjects with pre-existing conditions of the knee or tibia that would confound an
interpretation of results.
- Subjects for whom surgery in the opposite knee is planned during the 6 months of
follow-up.
- Subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy
within the past 5 years, except subjects with a history of basal skin carcinoma.
Other exclusion applies.