Outcome measurements
pain
ADVERSE EVENTS, SECONDARY, OSTEOARTHRITIS
The primary endpoint of this study was the VAS (100-mm) change rate for WBP at 16 weeks compared with baseline. The secondary endpoints were as follows: (1) VAS (100-mm) change rate for WBP at 8 weeks compared to baseline; (2) VAS (100-mm) changes in WBP at 8 and 16 weeks compared to baseline; (3) VAS (100-mm) change, and rate of change in resting and walking pain at 8 and 16 weeks compared to baseline; (4) the rate of change in Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC) scores at 8 and 16 weeks compared to baseline; (5) improvement of Clinical Global Impression (CGI), and Patients Global Impression (PGI) at 8 and 16 weeks compared to baseline; (6) evaluation of quality of life (EQ-5D) at 8 and 16 weeks compared to baseline, and (7) consumption of rescue medicine (acetaminophen) after visiting baseline. For safety analyses, all systemic and local adverse events (AEs) data were collected from the safety set population, and their severity and relationship with study intervention data were analyzed. Treatments for the management of AEs and AEs leading to the discontinuation of the study were also evaluated. The vital signs of patients were also evaluated at every visit.