Table 6 Secondary study endpoints

1. Difference between the treatment groups in proportion of subjects with a lower limb pain visual analog scale (VAS) score of not more than 3.0 cm at 3 months.

2. Difference between the treatment groups in crossover rates.

3. Difference between the treatment groups in responder rates at 6 months.

4. Difference between the treatment groups in the proportion of remitters (remission is defined as having a lower limb pain VAS score of not more than 3.0 cm for at least 6 months) at 6 months.

5. Difference between the treatment groups in the proportion of subjects with improvement from baseline in neurological assessment (motor, sensory, or reflex) at 3 months.

6. Difference between the treatment groups in the proportion of subjects with overall improvement from baseline in neurological assessment (motor, sensory, or reflex) at 6 months.

7. Difference between the treatment groups in changes in health-related quality of life as assessed by the EuroQol Five Dimensions questionnaire (EQ-5D-5L) at 6 months.

8. Difference between the treatment groups in the average percentage change from baseline in hemoglobin A1c (HbA_1c) levels at 6 months.