The NPRS of pain intensity is an 11-point numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participants were asked to select a whole number (0 to 10) that best indicates the intensity of his/her neuropathic pain in the past 24 hours. The weekly average score of NPRS was defined as the sum of non-missing daily scores divided by the number of days with non-missing scores for that week. Negative change from baseline indicates decreased pain intensity.

The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants evaluable for this outcome measure analysis.

An adverse event (AE) was any unfavorable and unintended sign (including any CS abnormal laboratory test result), symptom, or disease temporally associated with use of the study drug, whether or not it is considered to be study drug related. An SAE was any untoward medical occurrence that at any dose resulted in death, in the view of Investigator, placed participant at immediate risk of death, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a birth defect. AEs that presented, or worsened in intensity or frequency, following the initiation of study treatment were categorized as TEAEs.

The safety analysis set includes all randomized participants who receive at least 1 dose of randomized study drug.

Clinically significant abnormalities in physical examinations were based on investigator discretion.

The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug.

Vital sign parameters included temperature, pulse rate systolic blood pressure, diastolic blood pressure, and respiratory rate. As pre-specified in protocol, the criteria for determining potentially clinically relevant abnormalities in vital signs included: temperature < 36.0 and > 38.0 degrees Celsius (c), pulse rate < 60 and > 100 beats per minute (bpm), systolic blood pressure < 90, > 140 and > 160 millimeters of mercury (mmHg), diastolic blood pressure < 50, > 90 and > 100 mmHg, weight (7% or more increase from baseline, 7% or more decrease from baseline) and respiratory rate < 12 and > 20 breaths per minute. The categories with at least one participant with clinically significant vital sign abnormalities are reported.

The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants evaluable for this outcome measure analysis.

Clinical significance of abnormalities in ECG was determined based on the investigator's discretion.

The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants evaluable for this outcome measure analysis.

Hematology parameters included hematocrit, hemoglobin, erythrocytes, leukocytes, neutrophils, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular hemoglobin, mean corpuscular volume, and mean corpuscular hemoglobin concentration. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline values. The categories with at least one participant with shift from baseline in these parameters are reported.

The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants available for this outcome measure analysis. 'Number analyzed' signifies the number of participants with data available for analysis at specified time-point.

Parameters included alanine aminotransferase (ALT), aspartate aminotransferase (AST), cholesterol, choriogonadotropin beta, follicle stimulating hormone (FSH), estimated glomerular filtration rate (eGFR), ferritin, creatine kinase, blood urea nitrogen, creatinine, bilirubin(total and direct), alkaline phosphatase, amylase, lipase, sodium, potassium, calcium, phosphorus, uric acid, total protein, glucose, albumin, lactate dehydrogenase, magnesium, chloride, bicarbonate, and gamma-glutamyl transferase. These parameters were flagged as low, normal or high relative to parameter's normal range or as unknown if no result was available, by Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. Categories with at least one participant with shift from baseline in these parameters are reported.

The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants available for this outcome measure analysis. 'Number analyzed' signifies the number of participants with data available for analysis at specified time-point.

Urinalysis included assessments of bacteria, Bilirubin, Calcium Oxalate Crystals, Choriogonadotropin Beta, Color, Erythrocytes, Glucose, Granular Casts, Hyaline Casts, Ketones, Leukocyte Esterase, Leukocytes, Nitrite, Occult Blood, Protein, red blood cells (RBC) Casts, Renal Epithelial Cells, Specific Gravity, Specimen Appearance, Squamous Epithelial Cells, Transitional Epithelial Cells, Triple Phosphate Crystals, Uric Acid Crystals, white blood cells (WBC) Casts and pH. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.

The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants available for this outcome measure analysis. 'Number analyzed' signifies the number of participants with data available for analysis at specified time-point.

Coagulation included assessments of prothrombin. The parameter was flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline.

The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants available for this outcome measure analysis. 'Number analyzed' signifies the number of participants with data available for analysis at specified time-point.

Weight decrease was characterized by a decrease of ≥7% from baseline and weight increase was characterized by an increase of ≥7% from baseline.

The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants evaluable for this outcome measure analysis.

Responders is defined as participants with at least >=30% reduction in neuropathic pain from baseline in the NPRS average neuropathic pain intensity at Week 12 and were analysed using a logistic regression. The NPRS of pain intensity is a numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participant was asked to select a whole number (0 to 10) that best indicates the intensity of his/her neuropathic pain in the past 24 hours. Lower scores indicate less pain.

The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug.

Responder is defined as participants with at least >=50% reduction in neuropathic pain from baseline in the NPRS average neuropathic pain intensity at Week 12. The NPRS of pain intensity is a numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participant was asked to select a whole number (0 to 10) that best indicates the intensity of his/her neuropathic pain in the past 24 hours.

The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug.

Rescue medication for diabetic peripheral neuropathic pain (DPNP) is in addition to standard of care medication (gabapentin, pregabalin or duloxetine) for DPNP. Rescue medication is intended to treat temporary elevations in a participant's DPNP and is intended to be used occasionally and not meant to be used for prolonged periods of time.

The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug.

The amount of rescue medication used per day during the 12-week treatment period was calculated as the total dosage recorded divided by total days of study drug exposure during the treatment period.

The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug.

Time to first occurrence of rescue medication use was defined as the time from first randomized dose to the first date of rescue medication use recorded in e-diary during the 12-week treatment period. If a participant withdraws from the study prior to week 12 and the participant did not take any rescue medication, then the participant will be censored on the last day in the study.

The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants with first occurrence of rescue medication use.

DSIS is a participant reported outcome that was developed to quantify sleep interference due to pain. The DSIS was completed daily by participants upon waking, preferably in the morning, to accurately capture variability in sleep interference due to pain, thus minimizing recall bias. Using the e-diary, participants assessed how neuropathic pain has interfered with their sleep during the past 24 hours. This score ranges from 0 to 10; 0 representing no interference with sleep to 10 representing complete inability to sleep, lower score indicating less pain interference during sleep. The weekly average score of DSIS was defined as the sum of non-missing daily scores divided by the number of days with non-missing scores for that week. A negative change from baseline indicates decreased interference in sleep due to pain.

The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants evaluable for this outcome measure analysis.