Trial Outcomes & Findings for Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN) (NCT NCT01455428)

NCT ID: NCT01455428

Last Updated: 2021-01-28

Results Overview

The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 223 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2021-01-28

Participant Flow

223 participants were randomized, as stated on clinicaltrials.gov. However, 1 was randomized by mistake, was considered a screen failure, and was not given any medication. As such, the actual number of participants randomized and assigned to treatment was 222.

Participant milestones

Measure	Pregabalin Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo Participants received matching placebo capsule(s) for a period of 10 weeks.
Overall Study STARTED	112	110
Overall Study Treated	111	109
Overall Study COMPLETED	98	92
Overall Study NOT COMPLETED	14	18

Reasons for withdrawal

Measure	Pregabalin Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo Participants received matching placebo capsule(s) for a period of 10 weeks.
Overall Study Protocol Violation	2	1
Overall Study Adverse Event	6	2
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	2	5
Overall Study Did not meet entrance criteria	0	2
Overall Study Insufficient clinical response	0	2
Overall Study Did not receive treatment	1	1
Overall Study Other	2	4

Baseline Characteristics

Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)

Baseline characteristics by cohort

Measure	Pregabalin n=111 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=109 Participants Participants received matching placebo capsule(s) for a period of 10 weeks.	Total n=220 Participants Total of all reporting groups
Age, Customized 18-44 years	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Age, Customized 45-64 years	39 participants n=5 Participants	47 participants n=7 Participants	86 participants n=5 Participants
Age, Customized More than or equal to (>=)65 years	68 participants n=5 Participants	59 participants n=7 Participants	127 participants n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	47 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	62 Participants n=7 Participants	119 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.

The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.

Outcome measures

Measure	Pregabalin n=111 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=108 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Baseline Mean Pain Score	5.93 units on a scale Standard Deviation 1.304	6.08 units on a scale Standard Deviation 1.266

PRIMARY outcome

Timeframe: Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)

Population: All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.

The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.

Outcome measures

Measure	Pregabalin n=111 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=108 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in Mean Pain Score at Endpoint	-1.81 units on a scale Standard Error 0.137	-1.09 units on a scale Standard Error 0.142

SECONDARY outcome

Timeframe: Baseline and weekly from Weeks 1 to 8

Population: The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication.

The DPRS consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week.

Outcome measures

Measure	Pregabalin n=111 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=109 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 Week 1 change from baseline	-0.62 units on a scale Standard Error 0.108	-0.12 units on a scale Standard Error 0.111
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 Week 2 change from baseline	-1.00 units on a scale Standard Error 0.109	-0.35 units on a scale Standard Error 0.112
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 Week 3 change from baseline	-1.23 units on a scale Standard Error 0.109	-0.65 units on a scale Standard Error 0.112
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 Week 4 change from baseline	-1.36 units on a scale Standard Error 0.110	-0.85 units on a scale Standard Error 0.114
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 Week 5 change from baseline	-1.50 units on a scale Standard Error 0.110	-0.99 units on a scale Standard Error 0.114
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 Week 6 change from baseline	-1.70 units on a scale Standard Error 0.110	-1.11 units on a scale Standard Error 0.114
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 Week 7 change from baseline	-1.78 units on a scale Standard Error 0.111	-1.07 units on a scale Standard Error 0.114
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 Week 8 change from baseline	-1.91 units on a scale Standard Error 0.111	-1.21 units on a scale Standard Error 0.114

SECONDARY outcome

Timeframe: Baseline

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.

Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.

Outcome measures

Measure	Pregabalin n=111 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=108 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Baseline Mean Sleep Interference Score	3.81 units on a scale Standard Deviation 2.436	4.54 units on a scale Standard Deviation 2.027

SECONDARY outcome

Timeframe: Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.

Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.

Outcome measures

Measure	Pregabalin n=111 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=108 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in Mean Sleep Interference Score at Endpoint	-1.24 units on a scale Standard Error 0.145	-0.70 units on a scale Standard Error 0.150

SECONDARY outcome

Timeframe: Baseline and weekly from Weeks 1 to 8

Population: The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication.

Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week.

Outcome measures

Measure	Pregabalin n=111 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=109 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8 Week 1 change from baseline	-0.52 units on a scale Standard Error 0.124	0.01 units on a scale Standard Error 0.128
Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8 Week 2 change from baseline	-0.82 units on a scale Standard Error 0.124	-0.16 units on a scale Standard Error 0.128
Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8 Week 3 change from baseline	-0.92 units on a scale Standard Error 0.125	-0.35 units on a scale Standard Error 0.129
Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8 Week 4 change from baseline	-0.96 units on a scale Standard Error 0.125	-0.51 units on a scale Standard Error 0.130
Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8 Week 5 change from baseline	-1.02 units on a scale Standard Error 0.126	-0.62 units on a scale Standard Error 0.130
Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8 Week 6 change from baseline	-1.13 units on a scale Standard Error 0.126	-0.74 units on a scale Standard Error 0.130
Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8 Week 7 change from baseline	-1.27 units on a scale Standard Error 0.126	-0.79 units on a scale Standard Error 0.130
Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8 Week 8 change from baseline	-1.31 units on a scale Standard Error 0.126	-0.84 units on a scale Standard Error 0.131

SECONDARY outcome

Timeframe: End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.

The DPRS consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) compared to baseline.

Outcome measures

Measure	Pregabalin n=111 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=108 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Percentage of 30 Percent (%) Responders at Endpoint	52.3 percentage of participants Interval 42.6 to 61.8	30.6 percentage of participants Interval 22.1 to 40.2

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 3, 5, and 8

Population: The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=the number of participants who were evaluable for this measure at the given time point.

SF-MPQ was assessed according to the participant's answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.

Outcome measures

Measure	Pregabalin n=111 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=109 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Affective score, Week 5 change (N=102, 95)	-0.85 units on a scale Standard Deviation 2.036	-0.59 units on a scale Standard Deviation 1.512
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Sensory score, Baseline	8.24 units on a scale Standard Deviation 5.276	8.00 units on a scale Standard Deviation 4.939
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Sensory score, Week 1 change (N=111, 106)	-1.68 units on a scale Standard Deviation 3.776	-0.29 units on a scale Standard Deviation 3.009
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Sensory score, Week 3 change (N=107, 101)	-2.97 units on a scale Standard Deviation 3.852	-1.05 units on a scale Standard Deviation 3.810
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Sensory score, Week 5 change (N=102, 96)	-3.31 units on a scale Standard Deviation 4.496	-1.79 units on a scale Standard Deviation 4.058
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Sensory score, Week 8 change (N=98, 93)	-3.61 units on a scale Standard Deviation 4.299	-1.94 units on a scale Standard Deviation 4.418
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Affective score, Baseline	1.25 units on a scale Standard Deviation 2.038	1.31 units on a scale Standard Deviation 2.124
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Affective score, Week 1 change (N=111, 105)	-0.61 units on a scale Standard Deviation 1.602	-0.28 units on a scale Standard Deviation 1.404
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Affective score, Week 3 change (N=107, 100)	-0.80 units on a scale Standard Deviation 1.772	-0.46 units on a scale Standard Deviation 1.507
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Affective score, Week 8 change (N=97,90)	-0.96 units on a scale Standard Deviation 1.941	-0.66 units on a scale Standard Deviation 1.630
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Total score, Baseline	9.50 units on a scale Standard Deviation 6.621	9.29 units on a scale Standard Deviation 6.465
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Total score, Week 1 change (N=111, 106)	-2.29 units on a scale Standard Deviation 4.486	-0.57 units on a scale Standard Deviation 3.494
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Total score, Week 3 change (N=107, 101)	-3.77 units on a scale Standard Deviation 4.761	-1.51 units on a scale Standard Deviation 4.654
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Total score, Week 5 change (N=102, 96)	-4.17 units on a scale Standard Deviation 5.632	-2.37 units on a scale Standard Deviation 5.035
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Total score, Week 8 change (N=98, 93)	-4.57 units on a scale Standard Deviation 5.117	-2.53 units on a scale Standard Deviation 5.308

SECONDARY outcome

Timeframe: Baseline

Population: The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure. Number of participants evaluable for PPI=110, 108

The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).

Outcome measures

Measure	Pregabalin n=111 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=109 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale VAS	60.39 units on a scale Standard Deviation 13.064	62.60 units on a scale Standard Deviation 12.252
Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale PPI	2.33 units on a scale Standard Deviation 0.940	2.42 units on a scale Standard Deviation 0.738

SECONDARY outcome

Timeframe: Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.

The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).

Outcome measures

Measure	Pregabalin n=110 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=106 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in Pain VAS From the SF-MPQ at Endpoint	-20.71 units on a scale Standard Error 1.412	-12.53 units on a scale Standard Error 1.451

SECONDARY outcome

Timeframe: Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.

The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).

Outcome measures

Measure	Pregabalin n=110 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=105 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in PPI Scale From the SF-MPQ at Endpoint	-0.79 units on a scale Standard Error 0.078	-0.42 units on a scale Standard Error 0.080

SECONDARY outcome

Timeframe: Baseline

Population: The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure.

The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflected greater impairment in the MOS-Sleep subscales. The MOS-Sleep Scale was used to evaluate sleep during the previous week.

Outcome measures

Measure	Pregabalin n=111 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=109 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Sleep problems index score	31.38 units on a scale Standard Deviation 20.691	29.27 units on a scale Standard Deviation 17.292
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Sleep disturbance score	36.09 units on a scale Standard Deviation 25.542	35.08 units on a scale Standard Deviation 22.365
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Snoring score	29.19 units on a scale Standard Deviation 32.450	30.83 units on a scale Standard Deviation 35.017
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Awaken short of breath score	9.91 units on a scale Standard Deviation 21.213	8.07 units on a scale Standard Deviation 18.282
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Quantity of sleep score	6.05 units on a scale Standard Deviation 1.534	5.97 units on a scale Standard Deviation 1.524
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Sleep adequacy score	57.66 units on a scale Standard Deviation 31.449	60.46 units on a scale Standard Deviation 29.008
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Somnolence score	32.25 units on a scale Standard Deviation 19.950	30.89 units on a scale Standard Deviation 17.816

SECONDARY outcome

Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.

Outcome measures

Measure	Pregabalin n=103 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=97 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint	-11.97 units on a scale Standard Error 1.821	-4.76 units on a scale Standard Error 1.871

SECONDARY outcome

Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.

Outcome measures

Measure	Pregabalin n=104 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=97 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint	-2.00 units on a scale Standard Error 2.043	-3.73 units on a scale Standard Error 2.131

SECONDARY outcome

Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.

Outcome measures

Measure	Pregabalin n=104 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=96 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint	-0.10 units on a scale Standard Error 1.895	0.26 units on a scale Standard Error 1.988

SECONDARY outcome

Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).

Outcome measures

Measure	Pregabalin n=101 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=96 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint	0.69 units on a scale Standard Error 0.108	0.25 units on a scale Standard Error 0.111

SECONDARY outcome

Timeframe: Day 57 (Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (consisted of all participants randomized to treatment that received at least 1 dose of study medication) with available data to contribute to the analysis.

The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.

Outcome measures

Measure	Pregabalin n=101 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=96 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Percentage of Participants Who Had Optimal Sleep at Endpoint	49.5 percentage of participants Interval 39.4 to 59.6	40.6 percentage of participants Interval 30.7 to 51.1

SECONDARY outcome

Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.

Outcome measures

Measure	Pregabalin n=103 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=97 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint	10.44 units on a scale Standard Error 2.325	8.64 units on a scale Standard Error 2.403

SECONDARY outcome

Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.

Outcome measures

Measure	Pregabalin n=104 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=97 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint	0.33 units on a scale Standard Error 1.613	-0.54 units on a scale Standard Error 1.668

SECONDARY outcome

Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.

Outcome measures

Measure	Pregabalin n=102 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=96 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint	-7.38 units on a scale Standard Error 1.427	-4.54 units on a scale Standard Error 1.471

SECONDARY outcome

Timeframe: Day 57 (Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician's perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).

Outcome measures

Measure	Pregabalin n=104 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=97 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Clinical Global Impression of Change (CGIC) Score at Endpoint	2.55 units on a scale Standard Error 0.086	3.18 units on a scale Standard Error 0.090

SECONDARY outcome

Timeframe: Day 57 (Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant's perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).

Outcome measures

Measure	Pregabalin n=104 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=97 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Patient Global Impression of Change (PGIC) Score at Endpoint	2.68 units on a scale Standard Error 0.083	3.17 units on a scale Standard Error 0.086

SECONDARY outcome

Timeframe: Baseline

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.

The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.

Outcome measures

Measure	Pregabalin n=111 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=109 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Baseline Hospital Anxiety and Depression Scale (HADS) Scores Anxiety total score	3.22 units on a scale Standard Deviation 3.921	3.37 units on a scale Standard Deviation 3.466
Baseline Hospital Anxiety and Depression Scale (HADS) Scores Depression total score	3.45 units on a scale Standard Deviation 3.963	3.47 units on a scale Standard Deviation 3.387

SECONDARY outcome

Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.

Outcome measures

Measure	Pregabalin n=104 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=97 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in HADS Anxiety Total Score at Endpoint	-0.92 units on a scale Standard Error 0.233	-0.71 units on a scale Standard Error 0.241

SECONDARY outcome

Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Population: All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.

Outcome measures

Measure	Pregabalin n=104 Participants Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=97 Participants Participants received matching placebo capsule(s) for a period of 10 weeks
Change From Baseline in HADS Depression Total Score at Endpoint	-0.65 units on a scale Standard Error 0.209	-0.55 units on a scale Standard Error 0.217

Adverse Events

Pregabalin

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pregabalin n=111 participants at risk Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=109 participants at risk Participants received matching placebo capsule(s) for a period of 10 weeks.
Infections and infestations Respiratory tract infection	0.90% 1/111 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 participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.	0.00% 0/109 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 participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.
Nervous system disorders Cerebral ischaemia	0.90% 1/111 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 participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.	0.00% 0/109 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 participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.

Other adverse events

Measure	Pregabalin n=111 participants at risk Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram \[mg\] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Placebo n=109 participants at risk Participants received matching placebo capsule(s) for a period of 10 weeks.
Gastrointestinal disorders Dry mouth	5.4% 6/111 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 participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.	2.8% 3/109 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 participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.
General disorders Oedema peripheral	6.3% 7/111 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 participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.	1.8% 2/109 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 participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.
Infections and infestations Nasopharyngitis	4.5% 5/111 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 participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.	8.3% 9/109 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 participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.
Nervous system disorders Dizziness	24.3% 27/111 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 participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.	3.7% 4/109 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 participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.
Nervous system disorders Somnolence	5.4% 6/111 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 participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.	4.6% 5/109 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 participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.

Additional Information

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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