Two years to determine any adverse events and Secondary Outcome...

Two years to determine any adverse events and Secondary Outcome relating to Opioid Usage (24 months). 12 months and a bit for low back pain results.

Primary Completion 24 months.

Primary Outcome Measures

1. Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score
   Low back pain intensity will be measured using a VAS ranging from 0-100 millimeter (mm). A score of 0 represents no pain and 100 represents worst possible pain.
   [Time Frame: Baseline and Month 12]
2. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
   [Time Frame: Up to Month 24]