Trial Outcomes & Findings for Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain (NCT NCT01512160)

NCT ID: NCT01512160

Last Updated: 2013-06-28

Results Overview

TOTPAR \[6\] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR \[6\]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 90 participants
• Primary outcome timeframe: 0 to 6 hours
• Results posted on: 2013-06-28

Participant Flow

Participant milestones

Measure	PF-04531083 1000 mg Single oral dose of PF-04531083 1000 milligram (mg) spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 millimeter (mm) on a 100 mm Visual Analogue Scale (VAS).	PF-04531083 2000 mg Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Overall Study STARTED	22	23	22	23
Overall Study COMPLETED	20	23	22	22
Overall Study NOT COMPLETED	2	0	0	1

Reasons for withdrawal

Measure	PF-04531083 1000 mg Single oral dose of PF-04531083 1000 milligram (mg) spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 millimeter (mm) on a 100 mm Visual Analogue Scale (VAS).	PF-04531083 2000 mg Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Overall Study Lost to Follow-up	1	0	0	0
Overall Study Withdrawal by Subject	1	0	0	1

Baseline Characteristics

Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain

Baseline characteristics by cohort

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Total n=90 Participants Total of all reporting groups
Age Continuous	22.9 years STANDARD_DEVIATION 3.7 • n=5 Participants	23.4 years STANDARD_DEVIATION 5.7 • n=7 Participants	25.3 years STANDARD_DEVIATION 4.5 • n=5 Participants	25.3 years STANDARD_DEVIATION 5.4 • n=4 Participants	24.2 years STANDARD_DEVIATION 4.9 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	23 Participants n=7 Participants	22 Participants n=5 Participants	23 Participants n=4 Participants	90 Participants n=21 Participants

PRIMARY outcome

Timeframe: 0 to 6 hours

Population: Full analysis set (FAS) included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing PR values were imputed using last observation carried forward (LOCF).

TOTPAR [6] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR [6]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Total Pain Relief (TOTPAR) Score From 0 to 6 Hours	4.3 units on a scale*hour Standard Error 1.5	4.4 units on a scale*hour Standard Error 1.5	8.8 units on a scale*hour Standard Error 1.5	5.3 units on a scale*hour Standard Error 1.5

SECONDARY outcome

Timeframe: 0 to 24 hours

Population: FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.

PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Number of Participants With Peak Pain Relief (PPR) None	4 participants	3 participants	3 participants	4 participants
Number of Participants With Peak Pain Relief (PPR) A Little	4 participants	6 participants	3 participants	4 participants
Number of Participants With Peak Pain Relief (PPR) Some	4 participants	7 participants	3 participants	4 participants
Number of Participants With Peak Pain Relief (PPR) A Lot	5 participants	0 participants	6 participants	5 participants
Number of Participants With Peak Pain Relief (PPR) Complete	5 participants	7 participants	7 participants	6 participants

SECONDARY outcome

Timeframe: 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM)

Population: FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.

PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete) at each relevant time points.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Time-specific Pain Relief (PR) Score 0 hours (n=22, 23, 22, 23)	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00
Time-specific Pain Relief (PR) Score 15 minutes (n=22, 23, 22, 23)	0.59 units on a scale Standard Deviation 0.80	0.78 units on a scale Standard Deviation 0.95	0.59 units on a scale Standard Deviation 0.91	0.57 units on a scale Standard Deviation 0.73
Time-specific Pain Relief (PR) Score 30 minutes (n=22, 23, 22, 23)	0.82 units on a scale Standard Deviation 0.85	1.04 units on a scale Standard Deviation 1.07	1.23 units on a scale Standard Deviation 1.23	1.04 units on a scale Standard Deviation 1.02
Time-specific Pain Relief (PR) Score 45 minutes (n=22, 23, 22, 23)	0.91 units on a scale Standard Deviation 0.87	1.26 units on a scale Standard Deviation 1.18	1.55 units on a scale Standard Deviation 1.22	1.35 units on a scale Standard Deviation 1.07
Time-specific Pain Relief (PR) Score 1 hour (n=22, 23, 22, 23)	0.86 units on a scale Standard Deviation 0.99	1.13 units on a scale Standard Deviation 1.06	1.73 units on a scale Standard Deviation 1.28	1.39 units on a scale Standard Deviation 1.34
Time-specific Pain Relief (PR) Score 1.5 hours (n=22, 23, 22, 23)	0.82 units on a scale Standard Deviation 0.91	0.91 units on a scale Standard Deviation 1.12	1.77 units on a scale Standard Deviation 1.38	1.30 units on a scale Standard Deviation 1.22
Time-specific Pain Relief (PR) Score 2 hours (n=15, 13, 20, 16)	1.07 units on a scale Standard Deviation 0.96	1.77 units on a scale Standard Deviation 0.93	1.90 units on a scale Standard Deviation 1.37	1.63 units on a scale Standard Deviation 1.26
Time-specific Pain Relief (PR) Score 3 hours (n=11, 10, 15, 12)	2.27 units on a scale Standard Deviation 0.79	2.30 units on a scale Standard Deviation 1.06	2.73 units on a scale Standard Deviation 0.96	2.25 units on a scale Standard Deviation 1.06
Time-specific Pain Relief (PR) Score 4 hours (n=11, 10, 15, 10)	2.27 units on a scale Standard Deviation 0.79	2.20 units on a scale Standard Deviation 0.92	2.87 units on a scale Standard Deviation 0.92	2.60 units on a scale Standard Deviation 1.17
Time-specific Pain Relief (PR) Score 6 hours (n=11, 9, 15, 9)	2.64 units on a scale Standard Deviation 0.67	2.67 units on a scale Standard Deviation 0.87	2.87 units on a scale Standard Deviation 0.92	3.11 units on a scale Standard Deviation 0.78
Time-specific Pain Relief (PR) Score 8 hours (n=10, 9, 15, 8)	2.70 units on a scale Standard Deviation 0.82	2.67 units on a scale Standard Deviation 1.32	2.60 units on a scale Standard Deviation 0.91	3.13 units on a scale Standard Deviation 0.83
Time-specific Pain Relief (PR) Score 24 hours (n=8, 7, 8, 7)	3.63 units on a scale Standard Deviation 0.52	3.86 units on a scale Standard Deviation 0.38	3.38 units on a scale Standard Deviation 0.74	3.71 units on a scale Standard Deviation 0.49
Time-specific Pain Relief (PR) Score Prior to RM (n=14, 16, 14, 16)	0.14 units on a scale Standard Deviation 0.36	0.25 units on a scale Standard Deviation 0.58	0.50 units on a scale Standard Deviation 0.65	0.25 units on a scale Standard Deviation 0.45

SECONDARY outcome

Timeframe: 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM

Population: FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.

Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Time-specific Pain Intensity Difference (PID) Score 24 hours (n=8, 7, 8, 7)	1.63 units on a scale Standard Deviation 0.52	1.86 units on a scale Standard Deviation 0.38	1.63 units on a scale Standard Deviation 0.74	1.86 units on a scale Standard Deviation 0.69
Time-specific Pain Intensity Difference (PID) Score 15 minutes (n=22, 23, 22, 23)	0.14 units on a scale Standard Deviation 0.64	0.17 units on a scale Standard Deviation 0.65	0.18 units on a scale Standard Deviation 0.39	0.17 units on a scale Standard Deviation 0.39
Time-specific Pain Intensity Difference (PID) Score 30 minutes (n=22, 23, 22, 23)	0.18 units on a scale Standard Deviation 0.73	0.35 units on a scale Standard Deviation 0.78	0.41 units on a scale Standard Deviation 0.67	0.35 units on a scale Standard Deviation 0.71
Time-specific Pain Intensity Difference (PID) Score 45 minutes (n=22, 23, 22, 23)	0.23 units on a scale Standard Deviation 0.69	0.30 units on a scale Standard Deviation 0.88	0.59 units on a scale Standard Deviation 0.67	0.35 units on a scale Standard Deviation 0.83
Time-specific Pain Intensity Difference (PID) Score 1 hour (n=22, 23, 22, 23)	0.14 units on a scale Standard Deviation 0.64	0.17 units on a scale Standard Deviation 0.83	0.68 units on a scale Standard Deviation 0.72	0.39 units on a scale Standard Deviation 1.03
Time-specific Pain Intensity Difference (PID) Score 1.5 hours (n=22, 23, 22, 23)	0.00 units on a scale Standard Deviation 0.69	0.04 units on a scale Standard Deviation 0.88	0.68 units on a scale Standard Deviation 0.78	0.26 units on a scale Standard Deviation 1.01
Time-specific Pain Intensity Difference (PID) Score 2 hours (n=15, 13, 20, 16)	0.13 units on a scale Standard Deviation 0.64	0.69 units on a scale Standard Deviation 0.48	0.75 units on a scale Standard Deviation 0.97	0.44 units on a scale Standard Deviation 0.96
Time-specific Pain Intensity Difference (PID) Score 3 hours (n=11, 10, 15, 12)	0.82 units on a scale Standard Deviation 0.40	1.00 units on a scale Standard Deviation 0.67	1.20 units on a scale Standard Deviation 0.68	0.83 units on a scale Standard Deviation 0.94
Time-specific Pain Intensity Difference (PID) Score 4 hours (n=11, 10, 15, 10)	0.91 units on a scale Standard Deviation 0.30	0.90 units on a scale Standard Deviation 0.57	1.20 units on a scale Standard Deviation 0.56	1.20 units on a scale Standard Deviation 0.63
Time-specific Pain Intensity Difference (PID) Score 6 hours (n=11, 9, 15, 9)	0.91 units on a scale Standard Deviation 0.30	1.22 units on a scale Standard Deviation 0.44	1.20 units on a scale Standard Deviation 0.68	1.44 units on a scale Standard Deviation 0.53
Time-specific Pain Intensity Difference (PID) Score 8 hours (n=10, 9, 15, 8)	1.00 units on a scale Standard Deviation 0.47	1.22 units on a scale Standard Deviation 0.67	1.20 units on a scale Standard Deviation 0.56	1.50 units on a scale Standard Deviation 0.76
Time-specific Pain Intensity Difference (PID) Score Prior to RM (n=14, 16, 14, 16)	-0.57 units on a scale Standard Deviation 0.51	-0.44 units on a scale Standard Deviation 0.51	-0.29 units on a scale Standard Deviation 0.61	-0.50 units on a scale Standard Deviation 0.52

SECONDARY outcome

Timeframe: 0 to 6, 0 to 24 hours

Population: FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing SPID values were imputed using LOCF.

Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. The SPID at 6 and 24 hours was derived by calculating the area under the PID effect curve through the first 6 or 24 hours post-dose respectively. The AUC was calculated using the trapezoid rule. Total score range: -6 (worst) to 18 (best) for SPID 0-6, and -24 (worst) to 72 (best) for SPID 0-24. Higher value of SPID indicated greater degree of pain relief.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours SPID 0-6	0.9 units on a scale*hour Standard Error 1.1	1.0 units on a scale*hour Standard Error 1.1	4.1 units on a scale*hour Standard Error 1.1	1.4 units on a scale*hour Standard Error 1.1
Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours SPID 0-24	4.7 units on a scale*hour Standard Error 5.4	5.6 units on a scale*hour Standard Error 5.3	13.3 units on a scale*hour Standard Error 5.4	5.7 units on a scale*hour Standard Error 5.3

SECONDARY outcome

Timeframe: 0 to 24 hours

Population: FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing TOTPAR values were imputed using LOCF.

TOTPAR [24] was defined as the area under the pain relief (PR) curve through the 24 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR assumed to be 0 at time=0. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 24 hours post-dose. Total score range for TOTPAR [24]: 0 (worst) - 96 (best), higher value of TOTPAR indicated greater degree of PR.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Total Pain Relief (TOTPAR) Score From 0 to 24 Hours	21.8 units on a scale*hour Standard Error 7.4	20.7 units on a scale*hour Standard Error 7.3	30.8 units on a scale*hour Standard Error 7.4	21.5 units on a scale*hour Standard Error 7.3

SECONDARY outcome

Timeframe: 0 to 24 hours

Population: FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.

Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Time to Onset of First Perceptible Pain Relief (PR)	0.4 hours Interval 0.2 to 0.8	0.3 hours Interval 0.2 to 0.4	0.4 hours Interval 0.3 to 0.5	0.4 hours Interval 0.3 to 0.5

SECONDARY outcome

Timeframe: 0 to 24 hours

Population: FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.

Participants evaluated the time to first meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Time to Onset of First Meaningful Pain Relief (PR)	3.0 hours Interval 2.5 to 5.6	4.9 hours Interval 2.0 to Upper limit of 90% confidence interval was not estimable due to empirical distribution of the data.	3.3 hours Interval 1.0 to 4.2	3.5 hours Interval 2.8 to 4.1

SECONDARY outcome

Timeframe: 1.5 to 24 hours

Population: FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.

Time to first use of rescue medication (2 tablets of acetaminophen 500 mg as starting dose) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Time to First Use of Rescue Medication	4.8 hours Interval 1.8 to Upper limit of 90% confidence interval was not estimable due to empirical distribution of the data.	2.6 hours Interval 1.7 to 10.4	11.1 hours Interval 2.4 to Upper limit of 90% confidence interval was not estimable due to empirical distribution of the data.	3.2 hours Interval 2.0 to 12.9

SECONDARY outcome

Timeframe: 0 to 24 hours

Population: FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.

Participants who did not experience adequate pain relief after 90 minutes post-dose of study medication had received 2 tablets of acetaminophen 500 mg as rescue medication.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Number of Participants With Rescue Medication	14 participants	16 participants	14 participants	16 participants

SECONDARY outcome

Timeframe: 6, 24 hours, prior to RM

Population: FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.

Participant rated the study medication that they received during the study, at both the 6 hour and 24 hour observations or at time of rescue medication, whichever occurs first, by answering the following question on 6-point categorical scale: how would you rate the study medication you received for pain? 5=excellent, 4=very good, 3=good, 2=fair and 1=poor.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Participant Global Evaluation of Study Medication 6 hours: Excellent	0 participants	2 participants	2 participants	1 participants
Participant Global Evaluation of Study Medication 6 hours: Very Good	2 participants	1 participants	10 participants	5 participants
Participant Global Evaluation of Study Medication 6 hours: Good	7 participants	4 participants	3 participants	3 participants
Participant Global Evaluation of Study Medication 6 hours: Fair	1 participants	2 participants	0 participants	0 participants
Participant Global Evaluation of Study Medication 6 hours: Poor	1 participants	0 participants	0 participants	0 participants
Participant Global Evaluation of Study Medication 6 hours: Not Done	11 participants	14 participants	7 participants	14 participants
Participant Global Evaluation of Study Medication 24 hours: Excellent	1 participants	2 participants	2 participants	4 participants
Participant Global Evaluation of Study Medication 24 hours: Very Good	5 participants	3 participants	5 participants	0 participants
Participant Global Evaluation of Study Medication 24 hours: Good	2 participants	2 participants	1 participants	3 participants
Participant Global Evaluation of Study Medication 24 hours: Fair	0 participants	0 participants	0 participants	0 participants
Participant Global Evaluation of Study Medication 24 hours: Poor	0 participants	0 participants	0 participants	0 participants
Participant Global Evaluation of Study Medication 24 hours: Not Done	14 participants	16 participants	14 participants	16 participants
Participant Global Evaluation of Study Medication Prior to RM: Excellent	0 participants	0 participants	1 participants	0 participants
Participant Global Evaluation of Study Medication Prior to RM: Very Good	0 participants	0 participants	4 participants	2 participants
Participant Global Evaluation of Study Medication Prior to RM: Good	2 participants	1 participants	2 participants	3 participants
Participant Global Evaluation of Study Medication Prior to RM: Fair	4 participants	4 participants	2 participants	2 participants
Participant Global Evaluation of Study Medication Prior to RM: Poor	8 participants	11 participants	5 participants	9 participants

SECONDARY outcome

Timeframe: 6, 24 hours, prior to RM

Population: FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.

Participant's response to 2 questions about "how satisfied or dissatisfied they were with the study medication for PR and overall performance (OP)" was obtained on a 5 point categorical scale, 1=very dissatisfied, 2=somewhat dissatisfied, 3=neither satisfied nor dissatisfied, 4=somewhat satisfied and 5=very satisfied.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Participant Satisfaction Questionnaire 24 hours OP: Somewhat Satisfied	4 participants	5 participants	0 participants	3 participants
Participant Satisfaction Questionnaire 24 hours OP: Neither Satisfied nor Dissatisfied	1 participants	0 participants	1 participants	0 participants
Participant Satisfaction Questionnaire 24 hours OP: Somewhat Dissatisfied	0 participants	0 participants	0 participants	0 participants
Participant Satisfaction Questionnaire 24 hours OP: Very Dissatisfied	0 participants	0 participants	0 participants	0 participants
Participant Satisfaction Questionnaire 24 hours OP: Not Done	14 participants	16 participants	14 participants	16 participants
Participant Satisfaction Questionnaire Prior to RM, PR: Very Satisfied	0 participants	0 participants	5 participants	0 participants
Participant Satisfaction Questionnaire Prior to RM, PR: Somewhat Satisfied	1 participants	1 participants	2 participants	4 participants
Participant Satisfaction Questionnaire Prior to RM, PR:Neither Satisfied nor Dissatisfied	1 participants	5 participants	0 participants	2 participants
Participant Satisfaction Questionnaire Prior to RM, PR: Somewhat Dissatisfied	4 participants	2 participants	2 participants	3 participants
Participant Satisfaction Questionnaire Prior to RM, PR: Very Dissatisfied	8 participants	8 participants	5 participants	7 participants
Participant Satisfaction Questionnaire Prior to RM, OP: Very Satisfied	0 participants	0 participants	3 participants	0 participants
Participant Satisfaction Questionnaire Prior to RM, OP: Somewhat Satisfied	1 participants	1 participants	4 participants	4 participants
Participant Satisfaction Questionnaire Prior to RM, OP:Neither Satisfied nor Dissatisfied	2 participants	5 participants	0 participants	2 participants
Participant Satisfaction Questionnaire Prior to RM, OP: Somewhat Dissatisfied	3 participants	2 participants	1 participants	3 participants
Participant Satisfaction Questionnaire Prior to RM, OP: Very Dissatisfied	8 participants	8 participants	6 participants	7 participants
Participant Satisfaction Questionnaire 6 hours PR: Very Satisfied	2 participants	1 participants	7 participants	4 participants
Participant Satisfaction Questionnaire 6 hours PR: Somewhat Satisfied	6 participants	3 participants	7 participants	4 participants
Participant Satisfaction Questionnaire 6 hours PR: Neither Satisfied nor Dissatisfied	1 participants	3 participants	1 participants	1 participants
Participant Satisfaction Questionnaire 6 hours PR: Somewhat Dissatisfied	2 participants	2 participants	0 participants	0 participants
Participant Satisfaction Questionnaire 6 hours PR: Very Dissatisfied	0 participants	0 participants	0 participants	0 participants
Participant Satisfaction Questionnaire 6 hours PR: Not Done	11 participants	14 participants	7 participants	14 participants
Participant Satisfaction Questionnaire 6 hours OP: Very Satisfied	3 participants	2 participants	5 participants	5 participants
Participant Satisfaction Questionnaire 6 hours OP: Somewhat Satisfied	6 participants	4 participants	9 participants	3 participants
Participant Satisfaction Questionnaire 6 hours OP: Neither Satisfied nor Dissatisfied	0 participants	2 participants	1 participants	1 participants
Participant Satisfaction Questionnaire 6 hours OP: Somewhat Dissatisfied	2 participants	0 participants	0 participants	0 participants
Participant Satisfaction Questionnaire 6 hours OP: Very Dissatisfied	0 participants	1 participants	0 participants	0 participants
Participant Satisfaction Questionnaire 6 hours OP: Not Done	11 participants	14 participants	7 participants	14 participants
Participant Satisfaction Questionnaire 24 hours PR: Very Satisfied	3 participants	4 participants	7 participants	4 participants
Participant Satisfaction Questionnaire 24 hours PR: Somewhat Satisfied	4 participants	3 participants	0 participants	3 participants
Participant Satisfaction Questionnaire 24 hours PR: Neither Satisfied nor Dissatisfied	1 participants	0 participants	1 participants	0 participants
Participant Satisfaction Questionnaire 24 hours PR: Somewhat Dissatisfied	0 participants	0 participants	0 participants	0 participants
Participant Satisfaction Questionnaire 24 hours PR: Very Dissatisfied	0 participants	0 participants	0 participants	0 participants
Participant Satisfaction Questionnaire 24 hours PR: Not Done	14 participants	16 participants	14 participants	16 participants
Participant Satisfaction Questionnaire 24 hours OP: Very Satisfied	3 participants	2 participants	7 participants	4 participants

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose

Population: Pharmacokinetic (PK) analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Maximum Observed Plasma Concentration (Cmax) of PF-04531083	5761 nanogram per milliliter (ng/mL) Standard Deviation 1905.0	9433 nanogram per milliliter (ng/mL) Standard Deviation 3527.0	—	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose

Population: PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083	4.02 hours Interval 1.02 to 6.28	6.00 hours Interval 2.02 to 24.2	—	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 4, 6 hours post-dose

Population: PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083	21920 nanogram*hour per milliliter (ng*hr/mL) Standard Deviation 7707.8	34640 nanogram*hour per milliliter (ng*hr/mL) Standard Deviation 16408.0	—	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose

Population: PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083	80140 ng*hr/mL Standard Deviation 23571	147100 ng*hr/mL Standard Deviation 49215	—	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose

Population: PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Maximum Observed Plasma Concentration (Cmax) of Ibuprofen (R)-Ibuprofen	10.93 microgram per milliliter (mcg/mL) Standard Deviation 4.6191	—	—	—
Maximum Observed Plasma Concentration (Cmax) of Ibuprofen (S)-Ibuprofen	12.10 microgram per milliliter (mcg/mL) Standard Deviation 3.7848	—	—	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose

Population: PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen (R)-Ibuprofen	4.02 hours Interval 1.0 to 24.1	—	—	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen (S)-Ibuprofen	4.02 hours Interval 1.02 to 6.23	—	—	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 4, 6 hours post-dose

Population: PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen (R)-Ibuprofen	31.39 microgram*hour per milliliter (mcg*h/mL) Standard Deviation 12.847	—	—	—
Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen (S)-Ibuprofen	38.72 microgram*hour per milliliter (mcg*h/mL) Standard Deviation 13.070	—	—	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose

Population: PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.

AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen (R)-Ibuprofen	56.82 mcg*hr/mL Standard Deviation 49.272	—	—	—
Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen (S)-Ibuprofen	82.58 mcg*hr/mL Standard Deviation 47.992	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Day 10-14 (Follow-up)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 to 14.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) AEs	13 participants	12 participants	11 participants	9 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) SAEs	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline up to Day 10-14 (Follow-up)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (urine pH, glucose, ketones, protein, blood, nitrite, leukocyte esterase), and clinical chemistry (glucose) were performed.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Number of Participants With Clinically Significant Laboratory Test Abnormality	4 participants	6 participants	5 participants	6 participants

SECONDARY outcome

Timeframe: Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.

Supine systolic and diastolic BP was measured after the participant has been rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg). The same arm and position and same size BP cuff was used throughout the study.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Supine Systolic and Diastolic Blood Pressure (BP) Screening: Systolic BP (n=22, 23, 22, 23)	124.3 mmHg Standard Deviation 9.70	123.2 mmHg Standard Deviation 9.62	122.4 mmHg Standard Deviation 10.05	126.5 mmHg Standard Deviation 10.22
Supine Systolic and Diastolic Blood Pressure (BP) Screening: Diastolic BP (n=22, 23, 22, 23)	71.4 mmHg Standard Deviation 8.75	69.7 mmHg Standard Deviation 6.33	71.4 mmHg Standard Deviation 6.99	72.8 mmHg Standard Deviation 8.31
Supine Systolic and Diastolic Blood Pressure (BP) Day 0: Systolic BP (n=22, 23, 22, 23)	128.2 mmHg Standard Deviation 14.41	122.4 mmHg Standard Deviation 10.14	126.7 mmHg Standard Deviation 11.15	128.0 mmHg Standard Deviation 10.80
Supine Systolic and Diastolic Blood Pressure (BP) Day 0: Diastolic BP (n=22, 23, 22, 23)	71.8 mmHg Standard Deviation 10.52	71.1 mmHg Standard Deviation 6.68	71.6 mmHg Standard Deviation 6.75	71.3 mmHg Standard Deviation 9.10
Supine Systolic and Diastolic Blood Pressure (BP) Day 1: Systolic BP (n=22, 23, 22, 23)	122.8 mmHg Standard Deviation 12.69	126.8 mmHg Standard Deviation 13.17	126.6 mmHg Standard Deviation 14.40	124.1 mmHg Standard Deviation 14.39
Supine Systolic and Diastolic Blood Pressure (BP) Day 1: Diastolic BP (n=22, 23, 22, 23)	67.2 mmHg Standard Deviation 8.89	71.1 mmHg Standard Deviation 9.59	72.5 mmHg Standard Deviation 9.61	70.7 mmHg Standard Deviation 11.51
Supine Systolic and Diastolic Blood Pressure (BP) Day 2: Systolic BP (n=22, 23, 22, 23)	121.2 mmHg Standard Deviation 10.51	119.3 mmHg Standard Deviation 10.52	124.0 mmHg Standard Deviation 11.39	122.2 mmHg Standard Deviation 12.31
Supine Systolic and Diastolic Blood Pressure (BP) Day 2: Diastolic BP (n=22, 23, 22, 23)	65.9 mmHg Standard Deviation 9.26	66.3 mmHg Standard Deviation 7.07	67.7 mmHg Standard Deviation 8.90	69.6 mmHg Standard Deviation 8.48
Supine Systolic and Diastolic Blood Pressure (BP) Day 10-14 (Follow-up): Systolic BP(n=21,23,22,22 )	122.8 mmHg Standard Deviation 11.05	124.9 mmHg Standard Deviation 10.70	125.4 mmHg Standard Deviation 11.14	122.5 mmHg Standard Deviation 10.18
Supine Systolic and Diastolic Blood Pressure (BP) Day 10-14 (Follow-up): Diastolic BP(n=21,23,22,22)	69.7 mmHg Standard Deviation 11.32	70.6 mmHg Standard Deviation 9.66	72.1 mmHg Standard Deviation 5.56	72.3 mmHg Standard Deviation 9.83

SECONDARY outcome

Timeframe: Screening, Day 1, 2, 10-14 (Follow-up)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.

Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization) and QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval).

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Screening: PR Interval (n=22, 23, 22, 23)	157.1 milliseconds Standard Deviation 27.69	156.0 milliseconds Standard Deviation 20.64	150.7 milliseconds Standard Deviation 23.17	156.4 milliseconds Standard Deviation 22.12
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Screening: QRS Interval (n=22, 23, 22, 23)	90.3 milliseconds Standard Deviation 8.33	95.8 milliseconds Standard Deviation 9.96	93.2 milliseconds Standard Deviation 8.74	93.7 milliseconds Standard Deviation 8.68
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Screening: QT Interval (n=22, 23, 22, 23)	398.4 milliseconds Standard Deviation 34.27	413.2 milliseconds Standard Deviation 34.29	410.7 milliseconds Standard Deviation 25.43	410.3 milliseconds Standard Deviation 26.56
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Screening: QTcF Interval (n=22, 23, 22, 23)	399.8 milliseconds Standard Deviation 16.34	403.6 milliseconds Standard Deviation 18.33	400.9 milliseconds Standard Deviation 16.33	404.0 milliseconds Standard Deviation 17.03
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Day 1: PR Interval (n=22, 23, 22, 23)	154.2 milliseconds Standard Deviation 21.51	148.7 milliseconds Standard Deviation 18.71	148.4 milliseconds Standard Deviation 23.81	152.5 milliseconds Standard Deviation 14.93
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Day 1: QRS Interval (n=22, 23, 22, 23)	89.7 milliseconds Standard Deviation 7.15	95.0 milliseconds Standard Deviation 9.96	91.5 milliseconds Standard Deviation 7.90	90.8 milliseconds Standard Deviation 8.96
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Day 1: QT Interval (n=22, 23, 22, 23)	372.0 milliseconds Standard Deviation 18.27	391.1 milliseconds Standard Deviation 27.39	388.7 milliseconds Standard Deviation 28.41	388.9 milliseconds Standard Deviation 28.00
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Day 1: QTcF Interval (n=22, 23, 22, 23)	388.5 milliseconds Standard Deviation 15.48	393.4 milliseconds Standard Deviation 18.82	395.3 milliseconds Standard Deviation 17.66	398.7 milliseconds Standard Deviation 15.14
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Day 2: PR Interval (n=22, 23, 22, 23)	156.9 milliseconds Standard Deviation 22.83	149.1 milliseconds Standard Deviation 17.79	150.8 milliseconds Standard Deviation 22.86	153.9 milliseconds Standard Deviation 18.33
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Day 2: QRS Interval (n=22, 23, 22, 23)	87.6 milliseconds Standard Deviation 7.63	93.7 milliseconds Standard Deviation 8.10	88.5 milliseconds Standard Deviation 11.73	90.4 milliseconds Standard Deviation 8.38
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Day 2: QT Interval (n=22, 23, 22, 23)	381.1 milliseconds Standard Deviation 24.91	395.5 milliseconds Standard Deviation 32.99	385.8 milliseconds Standard Deviation 32.91	396.7 milliseconds Standard Deviation 26.22
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Day 2: QTcF Interval (n=22, 23, 22, 23)	394.0 milliseconds Standard Deviation 14.76	397.9 milliseconds Standard Deviation 18.87	396.6 milliseconds Standard Deviation 19.03	404.2 milliseconds Standard Deviation 16.82
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Day 10-14 (Follow-up): PR Interval (n=0, 0, 0, 1)	NA milliseconds Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	NA milliseconds Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	NA milliseconds Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	148.0 milliseconds Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Day 10-14 (Follow-up): QRS Interval (n=0, 0, 0, 1)	NA milliseconds Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	NA milliseconds Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	NA milliseconds Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	102.0 milliseconds Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Day 10-14 (Follow-up): QT Interval (n=0, 0, 0, 1)	NA milliseconds Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	NA milliseconds Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	NA milliseconds Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	360.0 milliseconds Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.
12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals) Day 10-14 (Follow-up): QTcF Interval(n=0, 0, 0, 1)	NA milliseconds Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	NA milliseconds Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	NA milliseconds Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	401.0 milliseconds Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.

SECONDARY outcome

Timeframe: Screening, Day 1, 2, 10-14 (Follow-up)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.

Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
12-Lead Electrocardiogram (ECG) Parameter (Heart Rate) Screening (n=22, 23, 22, 23)	62.2 beats per minute Standard Deviation 11.99	57.1 beats per minute Standard Deviation 10.02	56.5 beats per minute Standard Deviation 8.05	58.0 beats per minute Standard Deviation 8.54
12-Lead Electrocardiogram (ECG) Parameter (Heart Rate) Day 1 (n=22, 23, 22, 23)	69.1 beats per minute Standard Deviation 10.30	61.7 beats per minute Standard Deviation 7.08	64.0 beats per minute Standard Deviation 9.51	65.8 beats per minute Standard Deviation 10.89
12-Lead Electrocardiogram (ECG) Parameter (Heart Rate) Day 2 (n=22, 23, 22, 23)	67.2 beats per minute Standard Deviation 9.83	62.5 beats per minute Standard Deviation 11.60	66.3 beats per minute Standard Deviation 10.09	64.3 beats per minute Standard Deviation 8.26
12-Lead Electrocardiogram (ECG) Parameter (Heart Rate) Day 10-14 (Follow-up) (n=0, 0, 0, 1)	NA beats per minute Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	NA beats per minute Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	NA beats per minute Standard Deviation NA As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.	83.0 beats per minute Standard Deviation NA Standard deviation was not estimable since only 1 participant was evaluable.

SECONDARY outcome

Timeframe: Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.

Supine pulse rate was measured in the brachial/radial artery for at least 30 seconds.

Outcome measures

Measure	PF-04531083 1000 mg n=22 Participants Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 Participants Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 Participants Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 Participants Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Supine Pulse Rate Screening (n=22, 23, 22, 23)	60.1 beats per minute Standard Deviation 13.08	56.2 beats per minute Standard Deviation 10.48	55.1 beats per minute Standard Deviation 7.97	57.0 beats per minute Standard Deviation 10.45
Supine Pulse Rate Day 0 (n=22,23,22,23)	61.6 beats per minute Standard Deviation 8.56	61.3 beats per minute Standard Deviation 9.89	62.1 beats per minute Standard Deviation 10.23	63.1 beats per minute Standard Deviation 12.40
Supine Pulse Rate Day 1 (n=22,23,22,23)	66.4 beats per minute Standard Deviation 10.06	59.5 beats per minute Standard Deviation 8.81	61.2 beats per minute Standard Deviation 7.32	59.4 beats per minute Standard Deviation 9.48
Supine Pulse Rate Day 2 (n=22,23,22,23)	64.1 beats per minute Standard Deviation 9.59	60.6 beats per minute Standard Deviation 12.03	65.9 beats per minute Standard Deviation 8.71	62.7 beats per minute Standard Deviation 8.55
Supine Pulse Rate Day 10-14 (Follow-up) (n=21, 23, 22, 22)	61.3 beats per minute Standard Deviation 9.91	60.4 beats per minute Standard Deviation 10.60	59.6 beats per minute Standard Deviation 11.81	62.0 beats per minute Standard Deviation 8.91

Adverse Events

PF-04531083 1000 mg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

PF-04531083 2000 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Ibuprofen 400 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PF-04531083 1000 mg n=22 participants at risk Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	PF-04531083 2000 mg n=23 participants at risk Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Ibuprofen 400 mg n=22 participants at risk Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.	Placebo n=23 participants at risk Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
Gastrointestinal disorders Nausea	18.2% 4/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.0% 3/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.6% 3/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	9.1% 2/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tooth infection	13.6% 3/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.1% 2/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood bilirubin increased	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.7% 2/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood bilirubin unconjugated increased	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.7% 2/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	22.7% 5/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	34.8% 8/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	27.3% 6/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	17.4% 4/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	17.4% 4/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.7% 2/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER