SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)

Inclusion Criteria:

• Subjects with single-level LDH (L4-L5 or L5-S1 (or L5-L6)) with clear, demonstrablenerve root impingement as assessed by magnetic resonance imaging (MRI) and clinicalsymptoms corresponding to position of the impaired nerve root.
• Subjects with radiculopathy/radicular leg pain in the unilateral leg for 6 weeks ormore but 1 year or less.
• Subjects with positive result of Straight Leg Raise (SLR) test (≤70°) only on theipsilateral leg having chief complaint of radiculopathy
• Subjects with inadequate improvement in pain caused by LDH despite 6 weeks or more ofconservative treatment.

Exclusion Criteria:

• Subjects who have 2 or more lumbar disc herniations as assessed by MRI.
• Subjects who have undergone a lumbar operation, lumbar percutaneous nucleotomy, orlumbar intradiscal therapies at the affected level of lumbar spine.
• Subjects who have received block procedure (e.g., spinal injection, epidural injectionor nerve block) for treatment of LDH, oral or injectable corticosteroids within 28days prior to randomization.
• Subjects who have received opioids or cannabis by any route of administration, localanesthesia to the back, buttock, or posterior/lateral aspects of the affected legwithin 7 days prior to randomization.
• Subjects with a body mass index (BMI) ≥40.
• Subjects who are receiving compensation according to the Workers' Compensation Act orare involved in personal injury litigation due to a lumbar-related injury.