Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain

Exclusion Criteria

• •1. Non-OA inflammatory arthritis
• •2. Confounding elements
• •3. Lower limb amputation.
• •4. Specified alternate historic treatments
• •5. Identified underlying physiologic or psychosocial conditions
• •6. Patient Health Questionnaire
• •7. Moderate to severe hepatic impairment
• •8. Moderate to severe renal impairment
• •9. Identifiable baseline medications
• •10. Protocol compliance requirements
• •11. Known allergies or hypersensitivity to identified agents
• •12. Identified alcohol or drug abuse history
• •13. Identified underlying physical exam findings: ECG abnormalities or vital sign abnormalities during study screening per investigator assessment
• •14. Identified underlying abnormal laboratory results