1. Safety issues in the development of treatments for osteoarthritis: recommendations of the Safety Considerations Working Group 
V. Strand, D.A. Bloch, R. Leff, P.M. Peloso, L.S. Simon 
Osteoarthritis and Cartilage 
Volume 19, Issue 5, Pages (May 2011)
DOI: /j.joca
Copyright © 2011 Osteoarthritis Research Society International Terms and Conditions

2. Fig. 1
Patient Exposure Recommendations from DM. Guidance Unlikely to Meet CV Risk Criteria. Power to exclude a Hazard Ratio or Risk Ratio of ≥1.8 or ≥1.3 based on SAEs of MACEs based on 3000 – 7000 patient-years exposure of the new therapy vs 2000 – 4000 of an active control with incidence of adverse events between 0.25 to 2%.
Osteoarthritis and Cartilage  , DOI: ( /j.joca )
Copyright © 2011 Osteoarthritis Research Society International Terms and Conditions