Outcome measurements and assessments
pain
ADVERSE EVENTS, EVENTS
According to the study protocol the primary endpoints of the present study were long-term safety as indicated through the rate of treatment emergent adverse events (TEAEs), and long-term efficacy of pain and function through American Shoulder and Elbow Surgeons Standardized Shoulder Assessment FormAdverse events in the present and the former studiesIn the former studyIn the present study, the aforementioned endpoints were assessed at 33.2 ± 1.0 (mean ± standard deviation) months post-treatment (range, 30.7–34.7) (first study visit; FSV) and at 40.6 ± 1.9 months post-treatment (range, 36.5–44.7) (second study visit; SSV).