4. The 24-hour average pain intensity (API) mean score for the baseline period is ≥ 4 and ≤ 8, [measured on the 11-point (0-10) (NRS)] with each individual score ≥ 3. In addition, the Oswestry Disability Index (ODI) score during the Randomization Visit is ≥ 30% and ≤ 60%.