Trial Outcomes & Findings for A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy (NCT NCT01006122)

NCT ID: NCT01006122

Last Updated: 2014-05-09

Results Overview

MWT measured ability of participant to remain awake. Participants were instructed to try and remain awake during series of six 20-minute periods in a semi-recumbent position in dark room. Each period was terminated immediately after sleep onset or at end of 20 minutes if no sleep occurred. Poorest outcome was 0 minute the best was 20 minutes.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 95 participants
• Primary outcome timeframe: Baseline, Day 21 of stable dosing phase
• Results posted on: 2014-05-09

Participant Flow

Participant milestones

Measure	PF-03654746 First, Then Placebo PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in the first double-blind (DB) intervention period then placebo matched to PF-03654746 orally once daily as PIC in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.	Placebo First Then, PF-03654746 Placebo matched to PF-03654746 orally once daily as PIC in the first DB intervention period then PF-03654746 at a starting dose of 0.25 mg to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as PIC in the TP at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week SP at fixed dose stabilized in the TP in the second DB intervention. A washout period of at least 7 days was maintained between each treatment period.
First Double-blind Intervention Period STARTED	47	48
First Double-blind Intervention Period COMPLETED	31	31
First Double-blind Intervention Period NOT COMPLETED	16	17
Wash-out Period (at Least 7 Days) STARTED	31	31
Wash-out Period (at Least 7 Days) COMPLETED	31	31
Wash-out Period (at Least 7 Days) NOT COMPLETED	0	0
Second Double-blind Intervention Period STARTED	31	31
Second Double-blind Intervention Period COMPLETED	29	24
Second Double-blind Intervention Period NOT COMPLETED	2	7

Reasons for withdrawal

Measure	PF-03654746 First, Then Placebo PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in the first double-blind (DB) intervention period then placebo matched to PF-03654746 orally once daily as PIC in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.	Placebo First Then, PF-03654746 Placebo matched to PF-03654746 orally once daily as PIC in the first DB intervention period then PF-03654746 at a starting dose of 0.25 mg to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as PIC in the TP at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week SP at fixed dose stabilized in the TP in the second DB intervention. A washout period of at least 7 days was maintained between each treatment period.
First Double-blind Intervention Period Lost to Follow-up	0	2
First Double-blind Intervention Period Protocol Violation	1	1
First Double-blind Intervention Period Pregnancy	0	1
First Double-blind Intervention Period Withdrawal by Subject	9	8
First Double-blind Intervention Period Does not meet entrance criteria	1	0
First Double-blind Intervention Period Lack of Efficacy	2	1
First Double-blind Intervention Period Other	3	0
First Double-blind Intervention Period Adverse Event	0	4
Second Double-blind Intervention Period Adverse Event	1	1
Second Double-blind Intervention Period Protocol Violation	1	0
Second Double-blind Intervention Period Lost to Follow-up	0	3
Second Double-blind Intervention Period Withdrawal by Subject	0	2
Second Double-blind Intervention Period Death	0	1

Baseline Characteristics

A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy

Baseline characteristics by cohort

Measure	Entire Study n=95 Participants Included all participants randomized to receive PF-03654746 first and placebo first.
Age, Continuous	32.1 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 21 of stable dosing phase

Population: Full analysis set (FAS) consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here "N"(number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specified time points for each arm.

MWT measured ability of participant to remain awake. Participants were instructed to try and remain awake during series of six 20-minute periods in a semi-recumbent position in dark room. Each period was terminated immediately after sleep onset or at end of 20 minutes if no sleep occurred. Poorest outcome was 0 minute the best was 20 minutes.

Outcome measures

Measure	PF-03654746 n=77 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase Baseline: n=77, 79	6.30 minutes Standard Deviation 4.155	5.81 minutes Standard Deviation 4.126
Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase Change at Day 21 (SP): n=54, 60	1.29 minutes Standard Deviation 4.518	1.10 minutes Standard Deviation 3.878

SECONDARY outcome

Timeframe: Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase

Population: FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here "n" signifies participants who were evaluable at specified time points for each arm, respectively.

ESS is a simple, self-administered questionnaire which provides a measurement of the participant's general level of daytime sleepiness. The participant rates the chance that he/she would fall asleep when in 8 different situations (e.g. sitting and reading, talking to someone, etc.) commonly encountered in daily life on a scale of 0 (no daytime sleep) to 3 (maximum daytime sleep). Total score was the sum of 8 situations ranges from 0 to 24 with a higher score indicating greater daytime sleepiness.

Outcome measures

Measure	PF-03654746 n=78 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Baseline: n=78, 79	16.54 units on a scale Standard Deviation 4.196	16.32 units on a scale Standard Deviation 4.407
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Change at Day 5 (TP): n=67, 78	-2.06 units on a scale Standard Deviation 2.928	-0.74 units on a scale Standard Deviation 2.770
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Change at Day 10 (TP): n=69, 76	-2.00 units on a scale Standard Deviation 3.325	-1.16 units on a scale Standard Deviation 3.402
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Change at Day 15 (TP): n=67, 74	-2.67 units on a scale Standard Deviation 3.933	-1.35 units on a scale Standard Deviation 4.053
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Change at Day 20 (TP): n=59, 65	-2.42 units on a scale Standard Deviation 3.944	-1.74 units on a scale Standard Deviation 4.542
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Change at Day 7 (SP): n=63, 67	-2.92 units on a scale Standard Deviation 4.386	-1.81 units on a scale Standard Deviation 4.743
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Change at Day 21 (SP): n=56, 61	-2.45 units on a scale Standard Deviation 3.765	-1.80 units on a scale Standard Deviation 5.231
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Change at Day 14 (SP): n=63, 67	-2.89 units on a scale Standard Deviation 4.618	-1.57 units on a scale Standard Deviation 4.762

SECONDARY outcome

Timeframe: Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase

Population: FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here "n" signifies participants who were evaluable at specified time points for each arm, respectively.

BFI is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. There are 3 questions that pertain specifically to level of fatigue and 6 questions regarding general activity level, mood and quality of life, all are answered on an 11-point scale, with "0" being "No fatigue at all" to "10" being "As bad as you can imagine". The global score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. Higher global scores are associated with more severe fatigue.

Outcome measures

Measure	PF-03654746 n=78 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Change at Day 15 (TP): n=67, 74	-1.18 units on a scale Standard Deviation 2.177	-0.78 units on a scale Standard Deviation 2.193
Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Change at Day 20 (TP): n=59, 65	-0.86 units on a scale Standard Deviation 2.104	-0.89 units on a scale Standard Deviation 1.816
Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Change at Day 7 (SP): n=63, 67	-0.96 units on a scale Standard Deviation 2.218	-1.07 units on a scale Standard Deviation 2.214
Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Change at Day 14 (SP): n=63, 67	-0.98 units on a scale Standard Deviation 2.195	-1.11 units on a scale Standard Deviation 2.146
Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Change at Day 21 (SP): n=56, 61	-0.74 units on a scale Standard Deviation 2.265	-1.09 units on a scale Standard Deviation 2.248
Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Baseline: n=78, 79	5.01 units on a scale Standard Deviation 2.564	5.02 units on a scale Standard Deviation 2.436
Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Change at Day 5 (TP): n=67, 78	-1.02 units on a scale Standard Deviation 2.116	-0.77 units on a scale Standard Deviation 1.900
Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase Change at Day 10 (TP): n=68, 76	-0.85 units on a scale Standard Deviation 1.928	-0.88 units on a scale Standard Deviation 1.668

SECONDARY outcome

Timeframe: Baseline, Day 7, 14, 21 of stable dosing phase

Population: FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here "N" (number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specified time points for each arm, respectively.

Cataplexy is a medical condition in which a person suffers sudden physical collapse though remaining conscious. Cataplexy episodes is number of counts the participant had cataplexy.

Outcome measures

Measure	PF-03654746 n=63 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=72 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Change From Baseline in Cataplexy Episodes at Day 7, 14, 21 of Stable Dosing Phase Baseline: n=63, 72	5.71 cataplexy episodes Standard Deviation 9.683	5.92 cataplexy episodes Standard Deviation 12.658
Change From Baseline in Cataplexy Episodes at Day 7, 14, 21 of Stable Dosing Phase Change at Day 7 (SP): n=53, 58	-1.91 cataplexy episodes Standard Deviation 6.473	-2.67 cataplexy episodes Standard Deviation 8.717
Change From Baseline in Cataplexy Episodes at Day 7, 14, 21 of Stable Dosing Phase Change at Day 14 (SP): n=51, 60	-1.71 cataplexy episodes Standard Deviation 7.103	-2.63 cataplexy episodes Standard Deviation 8.471
Change From Baseline in Cataplexy Episodes at Day 7, 14, 21 of Stable Dosing Phase Change at Day 21 (SP): n=44, 57	-2.09 cataplexy episodes Standard Deviation 7.882	-2.95 cataplexy episodes Standard Deviation 9.720

SECONDARY outcome

Timeframe: Baseline, Day 21 of stable dosing phase

Population: FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here "n" signifies participants who were evaluable at specified time points for each arm, respectively.

SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality, social functioning (SF), role emotional (RE) and mental health (MH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Outcome measures

Measure	PF-03654746 n=78 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Baseline: PF (n=78, 79)	79.68 units on a scale Standard Deviation 22.554	80.38 units on a scale Standard Deviation 22.882
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Baseline: RP (n=77, 79)	61.20 units on a scale Standard Deviation 31.305	65.19 units on a scale Standard Deviation 30.482
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Baseline: BP (n=78, 79)	68.97 units on a scale Standard Deviation 24.685	73.89 units on a scale Standard Deviation 26.619
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Baseline: GH (n=78, 79)	71.15 units on a scale Standard Deviation 16.701	73.03 units on a scale Standard Deviation 18.660
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Baseline: Vitality (n=78, 79)	38.46 units on a scale Standard Deviation 23.560	38.69 units on a scale Standard Deviation 21.443
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Baseline: SF (n=78, 79)	68.11 units on a scale Standard Deviation 28.536	69.30 units on a scale Standard Deviation 26.690
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Baseline: RE (n=77, 79)	79.65 units on a scale Standard Deviation 26.782	79.01 units on a scale Standard Deviation 26.550
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Baseline: MH (n=78, 79)	74.62 units on a scale Standard Deviation 15.411	77.34 units on a scale Standard Deviation 15.209
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Change at Day 21 (SP): PF (n=55, 61)	0.55 units on a scale Standard Deviation 15.174	4.75 units on a scale Standard Deviation 15.450
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Change at Day 21 (SP): RP (n=54, 61)	1.16 units on a scale Standard Deviation 22.191	-1.54 units on a scale Standard Deviation 27.235
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Change at Day 21 (SP): BP (n=55, 61)	1.02 units on a scale Standard Deviation 16.455	2.23 units on a scale Standard Deviation 20.078
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Change at Day 21 (SP): GH (n=55, 61)	-0.95 units on a scale Standard Deviation 11.762	0.52 units on a scale Standard Deviation 10.062
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Change at Day 21 (SP): Vitality (n=55, 61)	1.93 units on a scale Standard Deviation 19.833	1.64 units on a scale Standard Deviation 22.329
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Change at Day 21 (SP): SF (n=55, 61)	-2.05 units on a scale Standard Deviation 18.283	3.48 units on a scale Standard Deviation 23.288
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Change at Day 21 (SP): RE (n=54, 61)	-0.93 units on a scale Standard Deviation 21.577	6.56 units on a scale Standard Deviation 23.477
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase Change at Day 21 (SP): MH (n=55, 61)	-2.45 units on a scale Standard Deviation 11.258	-0.25 units on a scale Standard Deviation 17.307

SECONDARY outcome

Timeframe: Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase

Population: FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here "N" (number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specified time points for each arm, respectively.

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: "Compared to your subject's condition at the beginning of treatment, how much has your subject changed?". Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

Outcome measures

Measure	PF-03654746 n=69 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=77 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Clinical Global Impression of Improvement (CGI-I) Scale Score Day 5 (TP): n=67, 77	3.51 units on a scale Standard Deviation 0.859	3.75 units on a scale Standard Deviation 0.905
Clinical Global Impression of Improvement (CGI-I) Scale Score Day 10 (TP): n=69, 76	3.48 units on a scale Standard Deviation 0.994	3.61 units on a scale Standard Deviation 0.850
Clinical Global Impression of Improvement (CGI-I) Scale Score Day 15 (TP): n=67, 74	3.36 units on a scale Standard Deviation 0.980	3.35 units on a scale Standard Deviation 1.052
Clinical Global Impression of Improvement (CGI-I) Scale Score Day 20 (TP): n=59, 65	3.34 units on a scale Standard Deviation 1.124	3.29 units on a scale Standard Deviation 1.071
Clinical Global Impression of Improvement (CGI-I) Scale Score Day 7 (SP): n=63, 67	3.16 units on a scale Standard Deviation 1.139	3.19 units on a scale Standard Deviation 1.076
Clinical Global Impression of Improvement (CGI-I) Scale Score Day 14 (SP): n=64, 67	3.11 units on a scale Standard Deviation 1.210	3.33 units on a scale Standard Deviation 1.021
Clinical Global Impression of Improvement (CGI-I) Scale Score Day 21 (TP): n=56, 60	3.25 units on a scale Standard Deviation 1.210	3.27 units on a scale Standard Deviation 1.177

SECONDARY outcome

Timeframe: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase

Population: FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here "n" signifies participants who were evaluable at specified time points for each arm, respectively.

GMLT: a cognitive test which assessed executive function. Participant was shown a 10 multiplied by 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Score ranges from 0 to infinity. Lower scores meant a better performance.

Outcome measures

Measure	PF-03654746 n=78 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT) Baseline: n=78, 79	48.71 errors Standard Deviation 19.91	53.19 errors Standard Deviation 27.33
Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT) Day 5 (TP): n=72, 79	48.49 errors Standard Deviation 21.24	48.32 errors Standard Deviation 23.68
Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT) Day 10 (TP): n=72, 78	44.88 errors Standard Deviation 15.41	43.59 errors Standard Deviation 17.24
Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT) Day 15 (TP): n=67, 75	44.54 errors Standard Deviation 16.73	44.36 errors Standard Deviation 18.11
Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT) Day 20 (TP): n=60, 66	43.17 errors Standard Deviation 17.09	45.47 errors Standard Deviation 19.82
Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT) Day 21 (SP): n=61, 65	44.48 errors Standard Deviation 17.45	47.02 errors Standard Deviation 25.52

SECONDARY outcome

Timeframe: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase

Population: FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here "n" signifies participants who were evaluable at specified time points for each arm, respectively.

Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (msec)]. Scores ranges from 2 (best) to 3.3 (worst). Lower scores meant a better performance.

Outcome measures

Measure	PF-03654746 n=78 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Computer Based Objective Cognition Testing (CogState) Detection Speed Day 21 (SP): n=61, 64	2.54 log10 msec Standard Deviation 0.12	2.54 log10 msec Standard Deviation 0.1
Computer Based Objective Cognition Testing (CogState) Detection Speed Baseline: n=78, 79	2.55 log10 msec Standard Deviation 0.13	2.55 log10 msec Standard Deviation 0.12
Computer Based Objective Cognition Testing (CogState) Detection Speed Day 5 (TP): n=73, 79	2.51 log10 msec Standard Deviation 0.1	2.52 log10 msec Standard Deviation 0.11
Computer Based Objective Cognition Testing (CogState) Detection Speed Day 10 (TP): n=72, 78	2.52 log10 msec Standard Deviation 0.1	2.52 log10 msec Standard Deviation 0.1
Computer Based Objective Cognition Testing (CogState) Detection Speed Day 15 (TP): n=67, 75	2.53 log10 msec Standard Deviation 0.12	2.53 log10 msec Standard Deviation 0.1
Computer Based Objective Cognition Testing (CogState) Detection Speed Day 20 (TP): n=60, 66	2.52 log10 msec Standard Deviation 0.11	2.52 log10 msec Standard Deviation 0.11

SECONDARY outcome

Timeframe: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase

Population: FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here "n" signifies participants who were evaluable at specified time points for each arm, respectively.

Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 msec). Score ranges from 2 (best) to 3.3 (worst). Lower scores meant a better performance.

Outcome measures

Measure	PF-03654746 n=78 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Computer Based Objective Cognition Testing (CogState) Identification Speed Baseline: n=78, 79	2.74 log10 msec Standard Deviation 0.11	2.72 log10 msec Standard Deviation 0.10
Computer Based Objective Cognition Testing (CogState) Identification Speed Day 5 (TP): n=72, 79	2.72 log10 msec Standard Deviation 0.09	2.72 log10 msec Standard Deviation 0.09
Computer Based Objective Cognition Testing (CogState) Identification Speed Day 10 (TP): n=72, 78	2.72 log10 msec Standard Deviation 0.10	2.73 log10 msec Standard Deviation 0.10
Computer Based Objective Cognition Testing (CogState) Identification Speed Day 15 (TP): n=67, 75	2.73 log10 msec Standard Deviation 0.09	2.73 log10 msec Standard Deviation 0.09
Computer Based Objective Cognition Testing (CogState) Identification Speed Day 20 (TP): n=60, 66	2.72 log10 msec Standard Deviation 0.08	2.73 log10 msec Standard Deviation 0.11
Computer Based Objective Cognition Testing (CogState) Identification Speed Day 21 (SP): n=61, 65	2.73 log10 msec Standard Deviation 0.10	2.73 log10 msec Standard Deviation 0.10

SECONDARY outcome

Timeframe: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase

Population: FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here "N" (number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specified time points for each arm, respectively.

One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root of the proportion of correct responses. Score ranges from 0 (worse) to 1.57 (best). Higher scores meant a better performance.

Outcome measures

Measure	PF-03654746 n=77 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Computer Based Objective Cognition Testing (CogState) One Card Learning Baseline: n=77, 79	1.01 arcsine (square root proportion correct) Standard Deviation 0.15	1.02 arcsine (square root proportion correct) Standard Deviation 0.13
Computer Based Objective Cognition Testing (CogState) One Card Learning Day 5 (TP): n=72, 79	1.01 arcsine (square root proportion correct) Standard Deviation 0.14	1.02 arcsine (square root proportion correct) Standard Deviation 0.13
Computer Based Objective Cognition Testing (CogState) One Card Learning Day 10 (TP): n=72,78	1.01 arcsine (square root proportion correct) Standard Deviation 0.13	1.02 arcsine (square root proportion correct) Standard Deviation 0.12
Computer Based Objective Cognition Testing (CogState) One Card Learning Day 15 (TP): n=67, 75	1.00 arcsine (square root proportion correct) Standard Deviation 0.14	1.01 arcsine (square root proportion correct) Standard Deviation 0.14
Computer Based Objective Cognition Testing (CogState) One Card Learning Day 20 (TP): n=59, 66	1.02 arcsine (square root proportion correct) Standard Deviation 0.17	1.02 arcsine (square root proportion correct) Standard Deviation 0.17
Computer Based Objective Cognition Testing (CogState) One Card Learning Day 21 (SP): n=61, 65	1.01 arcsine (square root proportion correct) Standard Deviation 0.16	1.02 arcsine (square root proportion correct) Standard Deviation 0.16

SECONDARY outcome

Timeframe: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase

Population: FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here "N" (number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specified time points for each arm, respectively.

CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Score ranges from 0 to infinity. Lower scores meant a better performance.

Outcome measures

Measure	PF-03654746 n=74 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=78 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL) Day 10 (TP): n=70, 78	36.64 errors Standard Deviation 54.25	30.54 errors Standard Deviation 42.4
Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL) Baseline: n=74, 75	48.42 errors Standard Deviation 57.11	46.4 errors Standard Deviation 52.59
Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL) Day 5 (TP): n=71, 77	37.18 errors Standard Deviation 48.03	37.01 errors Standard Deviation 48.86
Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL) Day 15 (TP): n=66, 75	27.59 errors Standard Deviation 36.84	25.52 errors Standard Deviation 37.39
Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL) Day 20 (TP): n=59, 65	29.9 errors Standard Deviation 40.17	19.49 errors Standard Deviation 27.69
Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL) Day 21 (SP): n=61, 64	31.75 errors Standard Deviation 42.8	24.98 errors Standard Deviation 32.13

SECONDARY outcome

Timeframe: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase

Population: FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here "N" (number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specified time points for each arm, respectively.

CogState had 5 outcome measures that measured the cognitive constructs. GMLT, detection, identification, one card learning and CPAL. GMLT score range: 0 (best) to infinity (worst), detection and identification score range: 2 (best) to 3.3 (worst); One card learning score range: 0 (worse) to 1.57 (best) and CPAL score range: 0 (best) to infinity (worst). The individual score was standardized at each assessment and was then averaged to yield a composite score; total possible score: minus infinity to plus infinity. Positive composite score=improved performance.

Outcome measures

Measure	PF-03654746 n=74 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Computer Based Objective Cognition Testing (CogState ) Composite Score Baseline: n=74, 79	0.02 Units on a scale Standard Deviation 0.72	0.06 Units on a scale Standard Deviation 0.6
Computer Based Objective Cognition Testing (CogState ) Composite Score Day 5 (TP): n=73, 79	0.19 Units on a scale Standard Deviation 0.62	0.19 Units on a scale Standard Deviation 0.58
Computer Based Objective Cognition Testing (CogState ) Composite Score Day 10 (TP): n=72, 78	0.21 Units on a scale Standard Deviation 0.58	0.23 Units on a scale Standard Deviation 0.55
Computer Based Objective Cognition Testing (CogState ) Composite Score Day 15 (TP): n=67, 75	0.19 Units on a scale Standard Deviation 0.54	0.21 Units on a scale Standard Deviation 0.53
Computer Based Objective Cognition Testing (CogState ) Composite Score Day 20 (TP): n=60, 66	0.24 Units on a scale Standard Deviation 0.56	0.25 Units on a scale Standard Deviation 0.59
Computer Based Objective Cognition Testing (CogState ) Composite Score Day 21 (SP): n=61, 65	0.16 Units on a scale Standard Deviation 0.67	0.17 Units on a scale Standard Deviation 0.66

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 7-10 days after Day 21 (stable dosing phase)

Population: Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here "N" (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Criteria for potential clinical concern in vital signs: supine and standing systolic blood pressure (BP) less than (<) 90 millimeter of mercury (mmHg), supine and standing diastolic BP <50 mmHg, supine and standing heart rate <40 beats per minute (bpm) or >140 bpm. Number of participants who met the criteria for potential clinical concern was reported.

Outcome measures

Measure	PF-03654746 n=74 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Number of Participants With Vital Signs Data Supine systolic BP: < 90 mmHg	2 participants	3 participants
Number of Participants With Vital Signs Data Standing systolic BP: < 90 mmHg	3 participants	5 participants
Number of Participants With Vital Signs Data Supine diastolic BP: <50 mmHg	0 participants	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Day 21 of stable dosing phase

Population: Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here "N" (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Laboratory parameters included 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 (protein, blood), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported.

Outcome measures

Measure	PF-03654746 n=74 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Number of Participants With Laboratory Abnormalities	57 participants	61 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Day 21 of stable dosing phase

Population: Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here "N" (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=200 msec, maximum Fridericia's correction of QT (QTcF) interval of 450 to <480 msec, 480 to <500 msec and >=500 msec. Number of participants who met the criteria for potential clinical concern in ECG findings were reported.

Outcome measures

Measure	PF-03654746 n=74 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Number of Participants With Electrocardiogram (ECG) Findings	4 participants	4 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase

Population: FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here "n" signifies participants who were evaluable at specified time points for each arm, respectively.

Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1(some questions are reversed so that high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range:0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create 7 scale scores and 2 sleep scale index. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), sleep quantity, snoring, awaken short of breath (ASoB), somnolence, sleep adequacy and optimal sleep; and a 9-item overall sleep problems index(SPI) I and II Subscales range from 0-100 except for sleep quantity (SQ) ranging from0 to 24. Except for sleep quantity, higher scores=greater impairment.

Outcome measures

Measure	PF-03654746 n=78 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Medical Outcomes Study (MOS) Sleep Scale Score Baseline: SD (n=78,79)	20.48 units on a scale Standard Deviation 18.869	22.26 units on a scale Standard Deviation 20.420
Medical Outcomes Study (MOS) Sleep Scale Score Baseline: Somnolence (n=78,79)	64.70 units on a scale Standard Deviation 24.409	66.50 units on a scale Standard Deviation 24.529
Medical Outcomes Study (MOS) Sleep Scale Score Baseline: Adequacy (n=78,79)	34.62 units on a scale Standard Deviation 27.666	34.18 units on a scale Standard Deviation 26.967
Medical Outcomes Study (MOS) Sleep Scale Score Baseline: Snore (n=78,79)	26.67 units on a scale Standard Deviation 31.196	22.53 units on a scale Standard Deviation 30.444
Medical Outcomes Study (MOS) Sleep Scale Score Baseline: ASoB (n=78,79)	14.10 units on a scale Standard Deviation 23.043	13.92 units on a scale Standard Deviation 23.173
Medical Outcomes Study (MOS) Sleep Scale Score Baseline: SQ (n=78,79)	7.24 units on a scale Standard Deviation 1.505	7.18 units on a scale Standard Deviation 1.607
Medical Outcomes Study (MOS) Sleep Scale Score Baseline: Optimal sleep (n=78,79)	0.58 units on a scale Standard Deviation 0.497	0.51 units on a scale Standard Deviation 0.503
Medical Outcomes Study (MOS) Sleep Scale Score Baseline: SPI I (n=78,79)	40.85 units on a scale Standard Deviation 17.576	42.53 units on a scale Standard Deviation 15.314
Medical Outcomes Study (MOS) Sleep Scale Score Baseline: SPI II (n=78,79)	41.04 units on a scale Standard Deviation 16.508	42.24 units on a scale Standard Deviation 14.486
Medical Outcomes Study (MOS) Sleep Scale Score Day 5 (TP): SD (n=67,78)	22.46 units on a scale Standard Deviation 20.818	19.15 units on a scale Standard Deviation 21.942
Medical Outcomes Study (MOS) Sleep Scale Score Day 5 (TP): Somnolence (n=67,78)	55.42 units on a scale Standard Deviation 27.834	58.89 units on a scale Standard Deviation 26.240
Medical Outcomes Study (MOS) Sleep Scale Score Day 5 (TP): Adequacy (n=67,78)	35.82 units on a scale Standard Deviation 28.292	36.92 units on a scale Standard Deviation 27.648
Medical Outcomes Study (MOS) Sleep Scale Score Day 5 (TP): Snore (n=67,78)	22.99 units on a scale Standard Deviation 29.182	18.46 units on a scale Standard Deviation 28.425
Medical Outcomes Study (MOS) Sleep Scale Score Day 5 (TP): ASoB (n=67,78)	8.66 units on a scale Standard Deviation 15.657	11.54 units on a scale Standard Deviation 20.263
Medical Outcomes Study (MOS) Sleep Scale Score Day 5 (TP): SQ (n=67,78)	7.04 units on a scale Standard Deviation 1.408	6.88 units on a scale Standard Deviation 1.494
Medical Outcomes Study (MOS) Sleep Scale Score Day 5 (TP): Optimal sleep (n=67,78)	0.48 units on a scale Standard Deviation 0.503	0.55 units on a scale Standard Deviation 0.501
Medical Outcomes Study (MOS) Sleep Scale Score Day 5 (TP): SPI I (n=67,78)	38.91 units on a scale Standard Deviation 17.315	38.46 units on a scale Standard Deviation 16.158
Medical Outcomes Study (MOS) Sleep Scale Score Day 5 (TP): SPI II (n=67,78)	38.38 units on a scale Standard Deviation 17.252	38.14 units on a scale Standard Deviation 15.509
Medical Outcomes Study (MOS) Sleep Scale Score Day 10 (TP): SD (n=69,76)	21.43 units on a scale Standard Deviation 20.637	16.94 units on a scale Standard Deviation 18.685
Medical Outcomes Study (MOS) Sleep Scale Score Day 10 (TP): Somnolence (69,76)	58.55 units on a scale Standard Deviation 26.516	59.74 units on a scale Standard Deviation 25.979
Medical Outcomes Study (MOS) Sleep Scale Score Day 10 (TP): Adequacy (n=69,76)	33.33 units on a scale Standard Deviation 27.422	35.66 units on a scale Standard Deviation 28.064
Medical Outcomes Study (MOS) Sleep Scale Score Day 10 (TP): Snore (n=69,76)	19.71 units on a scale Standard Deviation 26.007	20.26 units on a scale Standard Deviation 27.999
Medical Outcomes Study (MOS) Sleep Scale Score Day 10 (TP): ASoB (n=69,76)	12.17 units on a scale Standard Deviation 21.204	7.89 units on a scale Standard Deviation 15.690
Medical Outcomes Study (MOS) Sleep Scale Score Day 10 (TP): SQ (n=69,76)	7.12 units on a scale Standard Deviation 1.255	6.99 units on a scale Standard Deviation 1.322
Medical Outcomes Study (MOS) Sleep Scale Score Day 10 (TP): Optimal sleep (n=69,76)	0.58 units on a scale Standard Deviation 0.497	0.58 units on a scale Standard Deviation 0.497
Medical Outcomes Study (MOS) Sleep Scale Score Day 10 (TP): SPI I (n=69,76)	40.10 units on a scale Standard Deviation 16.626	37.76 units on a scale Standard Deviation 15.929
Medical Outcomes Study (MOS) Sleep Scale Score Day 10 (TP): SPI II (n=69,76)	39.70 units on a scale Standard Deviation 16.628	37.03 units on a scale Standard Deviation 14.711
Medical Outcomes Study (MOS) Sleep Scale Score Day 15 (TP): SD (n=67,74)	22.03 units on a scale Standard Deviation 21.177	17.11 units on a scale Standard Deviation 20.585
Medical Outcomes Study (MOS) Sleep Scale Score Day 15 (TP): Somnolence (67,74)	53.93 units on a scale Standard Deviation 26.072	58.11 units on a scale Standard Deviation 28.467
Medical Outcomes Study (MOS) Sleep Scale Score Day 15 (TP): Adequacy (n=67,74)	36.27 units on a scale Standard Deviation 29.379	38.78 units on a scale Standard Deviation 29.188
Medical Outcomes Study (MOS) Sleep Scale Score Day 15 (TP): Snore (n=67,74)	19.70 units on a scale Standard Deviation 26.627	16.49 units on a scale Standard Deviation 26.350
Medical Outcomes Study (MOS) Sleep Scale Score Day 15 (TP): ASoB (n=67,74)	12.24 units on a scale Standard Deviation 22.551	11.35 units on a scale Standard Deviation 22.715
Medical Outcomes Study (MOS) Sleep Scale Score Day 15 (TP): SQ (n=67,74)	6.90 units on a scale Standard Deviation 1.293	7.15 units on a scale Standard Deviation 1.279
Medical Outcomes Study (MOS) Sleep Scale Score Day 15 (TP): Optimal sleep (n=67,74)	0.60 units on a scale Standard Deviation 0.494	0.64 units on a scale Standard Deviation 0.485
Medical Outcomes Study (MOS) Sleep Scale Score Day 15 (TP): SPI I (n=67,74)	38.71 units on a scale Standard Deviation 18.294	36.67 units on a scale Standard Deviation 16.889
Medical Outcomes Study (MOS) Sleep Scale Score Day 15 (TP): SPI II (n=67,74)	38.05 units on a scale Standard Deviation 17.748	36.28 units on a scale Standard Deviation 16.884
Medical Outcomes Study (MOS) Sleep Scale Score Day 20 (TP): SD (n=59,65)	22.99 units on a scale Standard Deviation 21.611	16.46 units on a scale Standard Deviation 17.522
Medical Outcomes Study (MOS) Sleep Scale Score Day 20 (TP): Somnolence (59,65)	56.05 units on a scale Standard Deviation 28.070	57.23 units on a scale Standard Deviation 28.720
Medical Outcomes Study (MOS) Sleep Scale Score Day 20 (TP): Adequacy (n=59,65)	36.95 units on a scale Standard Deviation 28.723	43.85 units on a scale Standard Deviation 30.088
Medical Outcomes Study (MOS) Sleep Scale Score Day 20 (TP): Snore (n=59,65)	22.37 units on a scale Standard Deviation 30.869	15.69 units on a scale Standard Deviation 23.316
Medical Outcomes Study (MOS) Sleep Scale Score Day 20 (TP): ASoB (n=59,65)	10.85 units on a scale Standard Deviation 17.936	8.92 units on a scale Standard Deviation 20.625
Medical Outcomes Study (MOS) Sleep Scale Score Day 20 (TP): SQ (n=59,65)	7.27 units on a scale Standard Deviation 1.257	7.40 units on a scale Standard Deviation 1.285
Medical Outcomes Study (MOS) Sleep Scale Score Day 20 (TP): Optimal sleep (n=59,65)	0.69 units on a scale Standard Deviation 0.464	0.68 units on a scale Standard Deviation 0.471
Medical Outcomes Study (MOS) Sleep Scale Score Day 20 (TP): SPI I (n=59,65)	39.32 units on a scale Standard Deviation 19.206	34.05 units on a scale Standard Deviation 16.240
Medical Outcomes Study (MOS) Sleep Scale Score Day 20 (TP): SPI II (n=59,65)	38.65 units on a scale Standard Deviation 18.858	34.02 units on a scale Standard Deviation 16.200
Medical Outcomes Study (MOS) Sleep Scale Score Day 7 (SP): SD (n=63,67)	20.73 units on a scale Standard Deviation 20.529	14.70 units on a scale Standard Deviation 18.250
Medical Outcomes Study (MOS) Sleep Scale Score Day 7 (SP): Somnolence (63,67)	49.84 units on a scale Standard Deviation 29.883	57.81 units on a scale Standard Deviation 30.003
Medical Outcomes Study (MOS) Sleep Scale Score Day 7 (SP): Adequacy (n=63,67)	40.63 units on a scale Standard Deviation 30.894	41.04 units on a scale Standard Deviation 29.032
Medical Outcomes Study (MOS) Sleep Scale Score Day 7 (SP): Snore (n=63,67)	19.37 units on a scale Standard Deviation 29.614	20.90 units on a scale Standard Deviation 28.801
Medical Outcomes Study (MOS) Sleep Scale Score Day 7 (SP): ASoB (n=63,67)	13.65 units on a scale Standard Deviation 23.231	8.96 units on a scale Standard Deviation 18.516
Medical Outcomes Study (MOS) Sleep Scale Score Day 7 (SP): SQ (n=63,67)	7.05 units on a scale Standard Deviation 1.184	7.21 units on a scale Standard Deviation 1.297
Medical Outcomes Study (MOS) Sleep Scale Score Day 7 (SP): Optimal sleep (n=63,67)	0.65 units on a scale Standard Deviation 0.481	0.66 units on a scale Standard Deviation 0.478
Medical Outcomes Study (MOS) Sleep Scale Score Day 7 (SP): SPI I (n=63,67)	36.19 units on a scale Standard Deviation 18.597	34.98 units on a scale Standard Deviation 16.518
Medical Outcomes Study (MOS) Sleep Scale Score Day 7 (SP): SPI II (n=63,67)	35.74 units on a scale Standard Deviation 18.159	34.43 units on a scale Standard Deviation 16.710
Medical Outcomes Study (MOS) Sleep Scale Score Day 14 (SP): SD (n=63,67)	23.37 units on a scale Standard Deviation 22.364	16.55 units on a scale Standard Deviation 19.925
Medical Outcomes Study (MOS) Sleep Scale Score Day 14 (SP): Somnolence (63,67)	51.53 units on a scale Standard Deviation 30.578	56.62 units on a scale Standard Deviation 28.554
Medical Outcomes Study (MOS) Sleep Scale Score Day 14 (SP): Adequacy (n=63,67)	41.27 units on a scale Standard Deviation 32.353	42.09 units on a scale Standard Deviation 33.099
Medical Outcomes Study (MOS) Sleep Scale Score Day 14 (SP): Snore (n=63,67)	19.37 units on a scale Standard Deviation 28.953	19.10 units on a scale Standard Deviation 27.509
Medical Outcomes Study (MOS) Sleep Scale Score Day 14 (SP): ASoB (n=63,67)	12.38 units on a scale Standard Deviation 20.138	10.45 units on a scale Standard Deviation 19.183
Medical Outcomes Study (MOS) Sleep Scale Score Day 14 (SP): SQ (n=63,67)	6.97 units on a scale Standard Deviation 1.282	7.19 units on a scale Standard Deviation 1.395
Medical Outcomes Study (MOS) Sleep Scale Score Day 14 (SP): Optimal sleep (n=63,67)	0.63 units on a scale Standard Deviation 0.485	0.67 units on a scale Standard Deviation 0.473
Medical Outcomes Study (MOS) Sleep Scale Score Day 14 (SP): SPI I (n=63,67)	37.99 units on a scale Standard Deviation 20.130	34.92 units on a scale Standard Deviation 19.283
Medical Outcomes Study (MOS) Sleep Scale Score Day 14 (SP): SPI II (n=63,67)	37.27 units on a scale Standard Deviation 20.493	34.92 units on a scale Standard Deviation 18.611
Medical Outcomes Study (MOS) Sleep Scale Score Day 21 (SP): SD (n=56,61)	21.27 units on a scale Standard Deviation 21.830	16.45 units on a scale Standard Deviation 17.791
Medical Outcomes Study (MOS) Sleep Scale Score Day 21 (SP): Somnolence (n=56,61)	53.93 units on a scale Standard Deviation 30.252	55.08 units on a scale Standard Deviation 30.133
Medical Outcomes Study (MOS) Sleep Scale Score Day 21 (SP): Adequacy (n=56,61)	35.71 units on a scale Standard Deviation 31.729	39.67 units on a scale Standard Deviation 30.874
Medical Outcomes Study (MOS) Sleep Scale Score Day 21 (SP): Snore (n=56,61)	20.36 units on a scale Standard Deviation 29.168	20.98 units on a scale Standard Deviation 29.081
Medical Outcomes Study (MOS) Sleep Scale Score Day 21 (SP): ASoB (n=56,61)	10.71 units on a scale Standard Deviation 17.874	6.89 units on a scale Standard Deviation 15.442
Medical Outcomes Study (MOS) Sleep Scale Score Day 21 (SP): SQ (n=56,61)	6.95 units on a scale Standard Deviation 1.432	7.38 units on a scale Standard Deviation 1.227
Medical Outcomes Study (MOS) Sleep Scale Score Day 21 (SP): Optimal sleep (n=56,61)	0.64 units on a scale Standard Deviation 0.483	0.69 units on a scale Standard Deviation 0.467
Medical Outcomes Study (MOS) Sleep Scale Score Day 21 (SP): SPI I (n=56,61)	38.93 units on a scale Standard Deviation 19.354	35.52 units on a scale Standard Deviation 17.919
Medical Outcomes Study (MOS) Sleep Scale Score Day 21 (SP): SPI II (n=56,61)	37.91 units on a scale Standard Deviation 19.436	34.78 units on a scale Standard Deviation 17.597

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase

Population: FAS. Here "n" signifies participants who were evaluable at specified time points for each arm, respectively. Results for a parameter are not reported at certain time points since none of the participants were evaluable for the parameter at those time points.

Sheehan-STS is an 8-item clinician/participant administered prospective rating scale and an indicator of trigger assessment that tracks both treatment-emergent suicidal ideation and behaviors). Items 1a, 2-6, 8 scored on 5-point Likert scale (0=not at all, 1=a little, 2=moderately, 3=very, and 4=extremely). Items 1, 1b, 7, an indicator of trigger assessment (TA) require yes/no response. Items included 1= Ever suffer any accident, 1a= Extent plan/intend to hurt yourself, 1b= Intend to die, 2= Wish dead, 3= Want to harm yourself, 4= Think about suicide, 5= Plan for a suicide, 6= Prepare for suicide (PS) with intent to die (ITD), 7= Injure yourself on purpose, 8= Attempt suicide. Result for item 1 indicates if any of the participant ever suffered any accident, 1b indicates if any of the participant intended to die, 7 indicates if any of the participant injured themselves purposely and trigger assessment indicates if any of the participant evoked trigger assessment.

Outcome measures

Measure	PF-03654746 n=78 Participants PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 Participants Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Baseline:Ever suffer any accident (n=78, 79)	0 participants	1 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Baseline:Hurt Yourself:Not at all (n=0,1)	0 participants	1 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Baseline:Wish dead:Not at all (n=78,79)	77 participants	79 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Baseline:Wish dead:A little (n=78,79)	1 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Baseline:Harm yourself:Not at all (n=78,79)	77 participants	79 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Baseline:Harm yourself:A little (n=78,79)	1 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Baseline:Think about suicide:Not at all (n=78,79)	77 participants	79 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Baseline:Think about suicide:A little (n=78, 79)	1 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Baseline:Plan suicide:Not at all (n=78, 79)	78 participants	79 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Baseline:PS with ITD:Not at all (n=78, 79)	78 participants	79 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Baseline:Injure yourself on purpose (n=78,79)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Baseline:Attempt suicide:Not at all (n=78, 79)	78 participants	79 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Baseline:Trigger assessment (n=78, 79)	1 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 5(TP):Ever suffer any accident (n=78,79)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 5(TP):Wish dead:Not at all (n=68,78)	68 participants	77 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 5(TP):Wish dead:A little (n=68, 78)	0 participants	1 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 5(TP):Harm yourself:Not at all (n=68,78)	68 participants	78 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 5(TP):Think about suicide:Not at all (n=68,78)	68 participants	78 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 5(TP):Plan suicide:Not at all (n=68,78)	68 participants	78 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 5(TP):PS with ITD:Not at all (n=68, 78)	68 participants	78 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 5(TP):Injure yourself on purpose (n=68,78)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 5(TP):Attempt suicide:Not at all (n=68,78)	68 participants	78 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 5(TP):Trigger assessment (n=68, 78)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 10(TP):Ever suffer any accident (n=69,76)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 10(TP):Intend to die (n=1,0)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 10(TP):Wish dead:Not at all (n=69, 76)	69 participants	76 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 10(TP):Harm yourself:Not at all (n=69,76)	69 participants	76 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 10(TP):Think About Suicide:Not at all(n=69,76)	69 participants	76 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 10(TP):Plan suicide:Not at all (n=69, 76)	69 participants	76 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 10(TP):PS with ITD:Not at all (n=69, 76)	69 participants	76 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 10(TP):Injure yourself on purpose (n=69,76)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 10(TP):Attempt suicide:Not at all (n=69, 76)	69 participants	76 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 10(TP):Trigger assessment (n=69, 76)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 15(TP):Ever suffer any accident (n=67,74)	0 participants	1 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 15(TP):Hurt Yourself:Not at all (n=0, 1)	0 participants	1 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 15(TP):Intend to die (n=2,0)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 15(TP):Wish dead:Not at all (n=67,74)	67 participants	74 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 15(TP):Harm yourself:Not at all (n=67,74)	67 participants	74 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 15(TP):Think about suicide:Not at all(n=67,74)	67 participants	73 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 15(TP):Think about suicide:A little (n=67,74)	0 participants	1 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 15(TP):Plan suicide:Not at all (n=67,74)	67 participants	74 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 15(TP):PS with ITD:Not at all (n=67,73)	67 participants	73 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 15(TP):Injure yourself on purpose (n=67,74)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 15(TP):Attempt suicide:Not at all (n=67, 74)	67 participants	74 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 15(TP):Trigger assessment (n=67,74)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 20(TP):Ever suffer any accident (n=58,64)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 20(TP):Wish dead:Not at all (n=58,64)	58 participants	63 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 20(TP):Wish dead:A little (n=58,64)	0 participants	1 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 20(TP):Harm yourself:Not at all (n=58,64)	58 participants	64 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 20(TP):Think about suicide:Not at all(n=58,64)	58 participants	64 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 20(TP):Plan suicide:Not at all (n=58,64)	58 participants	64 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 20(TP):PS with ITD:Not at all (n=58,64)	58 participants	64 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 20(TP):Injure yourself on purpose (n=58,64)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 20(TP):Attempt suicide:Not at all (n=58, 64)	58 participants	64 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 20(TP):Trigger assessment (n=58, 64)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 7(SP):Ever suffer any accident (n=63,67)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 7(SP):Intend to die (n=0,1)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 7(SP):Wish dead:Not at all (n=63,67)	63 participants	67 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 7(SP):Harm yourself:Not at all (n=63,67)	63 participants	67 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 7(SP):Think about suicide:Not at all(n=63,67)	63 participants	67 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 7(SP):Plan suicide:Not at all (n=63,67)	63 participants	67 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 7(SP):PS with ITD:Not at all (n=63,67)	63 participants	67 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 7(SP):Injure yourself on purpose (n=63,67)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 7(SP):Attempt suicide:Not at all (n=63,67)	63 participants	67 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 7(SP):Trigger assessment (n=63, 67)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 14(SP):Ever suffer any accident (n=63,67)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 14(SP):Intend to die (n=1,0)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 14(SP):Wish dead:Not at all (n=63,67)	62 participants	67 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 14(SP):Wish dead:A little (n=63,67)	1 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 14(SP):Harm yourself:Not at all (n=63,67)	63 participants	67 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 14(SP):Think about suicide:Not at all(n=63,67)	63 participants	67 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 14(SP):Plan suicide:Not at all (n=63,67)	63 participants	67 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 14(SP):PS with ITD:Not at all (n=63, 67)	63 participants	67 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 14(SP):Injure yourself on purpose (n=63,67)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 14(SP):Attempt suicide:Not at all (n=63, 67)	63 participants	67 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 14(SP):Trigger assessment (n=64,67)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 21(SP):Ever suffer any accident (n=56, 61)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 21(SP):Wish dead:Not at all (n=56,61)	56 participants	61 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 21(SP):Harm yourself:Not at all (n=56,61)	56 participants	61 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 21(SP):Think about suicide:Not at all(n=56,61)	56 participants	61 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 21(SP):Plan suicide:Not at all (n=56,61)	56 participants	61 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 21(SP):PS with ITD:Not at all (n=56,61)	56 participants	61 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 21(SP):Injure yourself on purpose (n=56,61)	0 participants	0 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 21(SP):Attempt suicide:Not at all (n=56,61)	56 participants	61 participants
Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS) Day 21(SP):Trigger assessment (n=56,61)	0 participants	0 participants

Adverse Events

PF-03654746

Serious events: 1 serious events

Other events: 48 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Measure	PF-03654746 n=78 participants at risk PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 participants at risk Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Injury, poisoning and procedural complications Injury	1.3% 1/78 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% 0/79 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.
Injury, poisoning and procedural complications Drug exposure during pregnancy	0.00% 0/78 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.	1.3% 1/79 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.

Other adverse events

Measure	PF-03654746 n=78 participants at risk PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.	Placebo n=79 participants at risk Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.3% 1/78 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% 0/79 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.
Skin and subcutaneous tissue disorders Cold sweat	1.3% 1/78 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% 0/79 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.
Cardiac disorders Palpitations	0.00% 0/78 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.	1.3% 1/79 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.
Ear and labyrinth disorders Ear discomfort	1.3% 1/78 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.	1.3% 1/79 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.
Ear and labyrinth disorders Vertigo	0.00% 0/78 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.	2.5% 2/79 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.
Eye disorders Eye irritation	1.3% 1/78 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.	1.3% 1/79 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.
Eye disorders Eye swelling	1.3% 1/78 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% 0/79 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.
Eye disorders Lacrimation increased	1.3% 1/78 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% 0/79 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 Abdominal distension	1.3% 1/78 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.	1.3% 1/79 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 Abdominal pain	1.3% 1/78 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.	1.3% 1/79 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 Abdominal pain upper	1.3% 1/78 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% 0/79 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 Chapped lips	1.3% 1/78 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% 0/79 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 Colitis	0.00% 0/78 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.	1.3% 1/79 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 Constipation	1.3% 1/78 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.	1.3% 1/79 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 Diarrhoea	3.8% 3/78 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.	3.8% 3/79 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 Dry mouth	5.1% 4/78 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% 0/79 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 Flatulence	1.3% 1/78 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.	1.3% 1/79 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 Gastritis	0.00% 0/78 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.	1.3% 1/79 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 Gastrooesophageal reflux disease	3.8% 3/78 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% 0/79 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 Nausea	5.1% 4/78 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.	7.6% 6/79 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 Tooth impacted	1.3% 1/78 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% 0/79 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 Toothache	1.3% 1/78 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.	2.5% 2/79 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	3.8% 3/78 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.	3.8% 3/79 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.
General disorders Chest pain	2.6% 2/78 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.	1.3% 1/79 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.
General disorders Fatigue	0.00% 0/78 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.	1.3% 1/79 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.
General disorders Feeling cold	1.3% 1/78 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% 0/79 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.
General disorders Feeling hot	1.3% 1/78 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% 0/79 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.
General disorders Feeling jittery	0.00% 0/78 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.	1.3% 1/79 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.
General disorders Irritability	3.8% 3/78 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.	1.3% 1/79 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.
General disorders Malaise	0.00% 0/78 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.	1.3% 1/79 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.
General disorders Pyrexia	2.6% 2/78 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.	1.3% 1/79 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.
General disorders Swelling	0.00% 0/78 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.	1.3% 1/79 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.
Immune system disorders Seasonal allergy	1.3% 1/78 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% 0/79 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 Gastroenteritis	1.3% 1/78 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% 0/79 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 Gastroenteritis viral	1.3% 1/78 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.	2.5% 2/79 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 Influenza	2.6% 2/78 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% 0/79 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 Nasopharyngitis	3.8% 3/78 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.	6.3% 5/79 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 Otitis externa	1.3% 1/78 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.	1.3% 1/79 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 Pneumonia	1.3% 1/78 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% 0/79 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 Sinusitis	1.3% 1/78 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.	1.3% 1/79 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 Upper respiratory tract infection	2.6% 2/78 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% 0/79 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 Urinary tract infection	1.3% 1/78 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.	1.3% 1/79 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.
Injury, poisoning and procedural complications Concussion	0.00% 0/78 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.	1.3% 1/79 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.
Injury, poisoning and procedural complications Contusion	5.1% 4/78 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% 0/79 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.
Injury, poisoning and procedural complications Excoriation	0.00% 0/78 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.	1.3% 1/79 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.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/78 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.	1.3% 1/79 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.
Injury, poisoning and procedural complications Joint sprain	1.3% 1/78 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.	1.3% 1/79 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.
Injury, poisoning and procedural complications Muscle strain	1.3% 1/78 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% 0/79 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.
Injury, poisoning and procedural complications Post concussion syndrome	0.00% 0/78 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.	1.3% 1/79 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 pressure increased	1.3% 1/78 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% 0/79 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 Hepatic enzyme increased	1.3% 1/78 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% 0/79 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 Semen volume decreased	0.00% 0/78 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.	1.3% 1/79 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.
Metabolism and nutrition disorders Decreased appetite	1.3% 1/78 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% 0/79 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.
Musculoskeletal and connective tissue disorders Back pain	2.6% 2/78 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.	3.8% 3/79 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.
Musculoskeletal and connective tissue disorders Groin pain	1.3% 1/78 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% 0/79 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.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/78 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.	1.3% 1/79 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.
Musculoskeletal and connective tissue disorders Myalgia	1.3% 1/78 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% 0/79 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.
Musculoskeletal and connective tissue disorders Pain in extremity	1.3% 1/78 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% 0/79 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 Burning sensation	1.3% 1/78 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% 0/79 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	2.6% 2/78 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.	1.3% 1/79 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 postural	1.3% 1/78 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% 0/79 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 Dysgeusia	1.3% 1/78 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% 0/79 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	12.8% 10/78 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.	7.6% 6/79 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 Migraine	1.3% 1/78 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.	1.3% 1/79 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 Somnolence	0.00% 0/78 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.	1.3% 1/79 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 Tremor	1.3% 1/78 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.	1.3% 1/79 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.
Psychiatric disorders Abnormal dreams	2.6% 2/78 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% 0/79 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.
Psychiatric disorders Aggression	0.00% 0/78 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.	1.3% 1/79 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.
Psychiatric disorders Anxiety	1.3% 1/78 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% 0/79 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.
Psychiatric disorders Depression	0.00% 0/78 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.	1.3% 1/79 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.
Psychiatric disorders Initial insomnia	1.3% 1/78 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.	1.3% 1/79 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.
Psychiatric disorders Insomnia	10.3% 8/78 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.	3.8% 3/79 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.
Psychiatric disorders Middle insomnia	2.6% 2/78 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.	2.5% 2/79 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.
Psychiatric disorders Mood altered	0.00% 0/78 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.	1.3% 1/79 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.
Psychiatric disorders Nervousness	1.3% 1/78 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% 0/79 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.
Psychiatric disorders Nicotine dependence	1.3% 1/78 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% 0/79 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.
Psychiatric disorders Nightmare	2.6% 2/78 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.	1.3% 1/79 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.
Psychiatric disorders Sleep disorder	1.3% 1/78 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% 0/79 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.
Psychiatric disorders Tension	1.3% 1/78 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% 0/79 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.
Reproductive system and breast disorders Benign prostatic hyperplasia	1.3% 1/78 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% 0/79 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.
Reproductive system and breast disorders Epididymitis	1.3% 1/78 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.	1.3% 1/79 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.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/78 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.	1.3% 1/79 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.
Reproductive system and breast disorders Galactorrhoea	1.3% 1/78 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% 0/79 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.
Reproductive system and breast disorders Menorrhagia	1.3% 1/78 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.	1.3% 1/79 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 Cough	5.1% 4/78 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.	2.5% 2/79 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 Dry throat	1.3% 1/78 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% 0/79 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 Dysphonia	1.3% 1/78 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% 0/79 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 Dyspnoea	1.3% 1/78 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% 0/79 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 Epistaxis	1.3% 1/78 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% 0/79 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 Hiccups	0.00% 0/78 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.	1.3% 1/79 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 Nasal congestion	1.3% 1/78 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.	1.3% 1/79 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	3.8% 3/78 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% 0/79 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.
Skin and subcutaneous tissue disorders Dermatitis contact	1.3% 1/78 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.	1.3% 1/79 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.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.3% 1/78 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% 0/79 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.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/78 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.	1.3% 1/79 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.
Skin and subcutaneous tissue disorders Pruritus	1.3% 1/78 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% 0/79 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.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/78 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.	1.3% 1/79 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.
Vascular disorders Flushing	1.3% 1/78 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% 0/79 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.
Vascular disorders Haematoma	0.00% 0/78 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.	1.3% 1/79 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.
Vascular disorders Hot flush	1.3% 1/78 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.	1.3% 1/79 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