Any clinically significant changes were recorded as adverse events. They are described in the adverse events section of the results.

AEs related to MRI, X-ray Imaging, Physical examination, and Neurologic examination are considered as adverse events of special interest (AESI). A treatment-emergent AE (TEAE) was defined as an AE that was not present prior to treatment with study drug, but appeared following treatment or was present at treatment initiation but worsened in severity during treatment.

Assessment of the number of participants with change in 12-lead ECG and CLT were assessed from baseline, 24 hours and 13 weeks.

The serum concentrations of KTP-001 were below the limit of quantification (BLQ) (<100 ng/mL) at all time points in all participants

Lower back and leg pain were assessed using an 11-point numerical rating scale (0 = "no pain" and 10 = "worst possible pain").

The endpoint was mean change from baseline at 6 and 13 weeks post-dose; with a negative number suggesting an improvement in pain while a positive number suggests a worsening in pain.

The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.

The changes to spinal flexion and tension were assessed using Straight-Leg Rising (SLR) and Femoral Stretch (FS) tests which are on a scale of no change, positive to negative or negative to positive and where a positive result for SLR may indicate between 30 and 70 degrees, where a positive result for FS may indicate pain in the anterior thigh of the test leg and the elicited pain.

The Oswestry Disability Index (ODI) score is calculated as participant score divided by possible score multiplied by 100, where the following scores can be interpreted to indicate:

0-20% = Minimal disability; 20-40% = Moderate disability; 40-60% = Severe disability; 60-80% = Crippled; 80-100% = Bed bound;

The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.

The endpoint was change from baseline at Week 6 and 13 hours post-dose. The Short Form-12 (SF-12) is a Quality of Life questionnaire which measures functional health and well-being from a participant's perspective across eight health domains. Each participant answers questions on a 5-point Likert scale, which rates responses according to how much the participant agrees or disagrees with a particular statement on their health and wellbeing, including vitality/physical functioning/bodily pain/general health perceptions/physical role functioning/emotional role functioning/social role functioning and mental health. Each scale is transformed into a 0-100 scale, assuming each question carries equal weight. Lower scores mean greater disability and higher scores mean less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.

The Patient Global Impression Change PGI-C scale was used where the scale ranges are from 1 (no change or condition has got worse) to 7 (a great deal better, and a considerable improvement). The endpoint was the value at 6 and 13 weeks post-dose.

The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.

The endpoint was change from baseline at 6 and 24 hours post-dose, and at the 1-, 2-, 4-, 6-, and 13-week follow-up visits or early termination visit.

The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.