TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24, with increasing scores indicating greater pain relief.

The population consisted of all participants that received at least one dose of study treatment and had at least one TOPAR6 observation up to 6 hours post initial dose of study medication.

The Pain Intensity Difference (PID) score is the difference between the baseline pain intensity (PI) score and the PI score recorded at each time point post initial dose, as calculated by subtracting the pain intensity at each of the subsequent time points from the baseline pain intensity score; therefore, it is on a -1 to 3 scale, with a large value representing a greater treatment effect. SPID6 is derived by multiplying the PID score at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours and it is on a scale of -6 to 18.

The population consisted of all participants that received at least one dose of study treatment, had at least one SPID6 observation up to 6 hours post initial dose of study medication, and had a baseline measurement.

The GLOBAL6 was recorded by the participant at 6 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL6 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.

The population consisted of all participants that received at least one dose of study treatment and had a GLOBAL6 observation at 6 hours post initial dose of study medication.

The GLOBAL24 was recorded by the participant at 24 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL24 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.

The population consisted of all participants that received at least one dose of study treatment had a GLOBAL24 observation at 24 hours post initial dose of study medication.

The time to a change from baseline in pain intensity score of >=1 unit on the pain intensity scale was calculated. The pain intensity scale rates participant pain on a scale of -1 to 3, with larger values associated with greater treatment effect.

The population consisted of all participants that received at least one dose of study treatment, had an observation at 6 hours post initial dose of study medication, and had a baseline measurement.

Peak PID during the 6 hours post initial dose is defined as the maximum PID score recorded during first 6 hours after the initial dose of study medication. PID is evaluated on a scale of -1 to 3, with larger values representing a greater treatment effect.

The population consisted of all participants that received at least one dose of study treatment and had a PID observation at up to 6 hours post initial dose of study medication.

Peak PR during the 6 hours post initial dose is defined as the maximum PR score

recorded during the first 6 hours after the initial dose of study medication. PR is recorded on a scale of 0 to 4, with 0 = no pain relief, 1 = little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.

The population consisted of all participants that received at least one dose of study treatment and had at least one Peak PR observation up to 6 hours post initial dose of study medication.

Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg (Saridon) was provided to each participant as rescue medication. Participants were permitted to take 2 tablets at a time and up to 3 doses within 24 hours of dosing of study drug for rescue purposes.

Due to the low number of participants requiring rescue medication use, the time to rescue medication use was not calculated.

PID during the 12 hours following the initial dose is defined as the maximum PID score recorded during first 12 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.

The population consisted of all participants that received at least one dose of study treatment and had at least one PID observation at up to 12 hours post initial dose of study medication.

PR during the 12 hours following the initial dose is defined as the maximum PR score recorded during the first 12 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.

The population consisted of all participants that received at least one dose of study treatment and had at least one PR observation up to 12 hours post initial dose of study medication.

PID during the 24 hours following the initial dose is defined as the maximum PID score recorded during first 24 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.

The population consisted of all participants that received at least one dose of study treatment and had at least one PID observation up to 24 hours post initial dose of study medication.

PR during the 24 hours following the initial dose is defined as the maximum PR score recorded during the first 24 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.

The population consisted of all participants that received at least one dose of study treatment and had at least one PR observation at up to 24 hours post initial dose of study medication.

At 6 hours following the initial dose. participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 6 hours post initial dose were summed.

The population consisted of all participants that received at least one dose of study treatment and completed the assessment at 6 hours post initial dose of study medication.

At 24 hours following the initial dose of study medication, participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 24 hours post initial dose were summed.

The population consisted of all participants that received at least one dose of study treatment and completed the assessment at 24 hours post initial dose of study medication