Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy

Exclusion Criteria

• •1. Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
• •2. Known intolerance to cannabinoids or cannabis products.
• •3. Participation in another clinical trial within the last four weeks prior to inclusion.
• •4. Pregnant or nursing women (as excluded by pregnancy testing at visit 1).
• •5. Other medical conditions that do not allow the trial subject to appraise the nature, scope, and potential consequences of the clinical trial
• •6. Indications that the trial subject is unlikely to comply with the study protocol (e.g., unwillingness to cooperate)
• •7. Known use of medicinal cannabis products within the last 8 weeks
• •8. Active malignant tumor disease, tumor pain, or other dominant severe pain other than that of the study indication
• •9. Known history of severe liver or kidney diseases
• •10. Known history of severe cardiovascular disease
• •11. Known history of or acute mental illness such as severe depression, psychosis, bipolar disorder, mania, anxiety, or obsessive-compulsive disorder
• •12. Known history of addictive disease (e.g., alcohol, medication, drug addiction)
• •13. Answered during Screening less than 12 times of 18 the pain intensity (NRS) inquiry
• •14. Laboratory liver values: Alanine aminotransferase (ALT, GPT) \> 3 x ULN (Upper Limit of Normal range), Aspartate aminotransferase (AST, GOT) \> 3 x ULN, Alkaline phosphatase (AP) \> 2.5 x ULN, and for bilirubin \> 1.5 x ULN
• •15. Laboratory renal value: Serum creatinine \> 1.5 ULN