Table 4.

Schedule of screening, enrollment, intervention, assessments, and follow-up visits in the clinical trial.

	Screening	Baseline	Day 8	Day 30	Day 60
Determine eligibility based on the inclusion and exclusion criteria	✓
Provision of participant information sheet	✓
Informed consent	✓
Recording of ODIa score	✓	✓	✓	✓	✓
Demographic and medical history	✓	✓
MRIb investigation	✓
Laboratory investigations	✓				✓
General physical examination	✓
Clinical examination	✓	✓	✓	✓	✓
Assessment of subjective parameters		✓	✓	✓	✓
Drug compliance assessment			✓	✓
Rescue medication assessment			✓	✓	✓
Adverse event assessment			✓	✓	✓

^aODI: Oswestry Disability Index.

^bMRI: magnetic resonance imaging.