Trial Outcomes & Findings for A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia (NCT NCT00599638)

NCT ID: NCT00599638

Last Updated: 2021-08-05

Results Overview

Pain was assessed by using a daily pain rating scale that consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"), higher scores indicate more pain intensity. Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily. The mean pain score was defined as the mean of the last 7 daily pain ratings scale scores while taking study medication, at end of each treatment period: Period 1 (Week 2) and Period 2 (Week 6), respectively. Mean pain score had a score range of 0 (no pain) to 10 (worst possible pain), higher scores indicate more pain. Cumulative data of mean pain scores at end of treatment for both the periods was calculated and reported in terms of adjusted mean and standard error.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 72 participants
• Primary outcome timeframe: End of treatment period (included both Week 2 and Week 6)
• Results posted on: 2021-08-05

Participant Flow

Participant milestones

Measure	Pregabalin Then Placebo Participants received 75 milligram (mg) capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first intervention period followed by placebo matched to Pregabalin twice daily from Day 1 to Day 14 in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.	Placebo Then Pregabalin Participants received placebo matched to Pregabalin twice daily from Day 1 to Day 14 in first intervention period followed by Pregabalin 75 mg capsule orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.	Pregabalin + Placebo Then Pregabalin + PF-00489791 Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with placebo matched to PF-00489791 orally once daily from Day 1 to Day 14 in first intervention period. In second intervention period participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 orally once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 orally once daily from Day 4 to Day 14. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.	Pregabalin + PF-00489791 Then Pregabalin + Placebo Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 orally once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 orally once daily from Day 4 to Day 14 in first intervention period. In second intervention period participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with a placebo matched to PF-00489791 orally once daily from Day 1 to Day 14. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.
First Intervention Period (2 Weeks) STARTED	16	14	20	22
First Intervention Period (2 Weeks) Treated	16	13	20	21
First Intervention Period (2 Weeks) COMPLETED	14	12	17	17
First Intervention Period (2 Weeks) NOT COMPLETED	2	2	3	5
Washout Period (2 Weeks) STARTED	14	12	17	17
Washout Period (2 Weeks) COMPLETED	13	11	17	14
Washout Period (2 Weeks) NOT COMPLETED	1	1	0	3
Second Intervention Period (2 Weeks) STARTED	13	11	17	14
Second Intervention Period (2 Weeks) COMPLETED	12	11	17	14
Second Intervention Period (2 Weeks) NOT COMPLETED	1	0	0	0

Reasons for withdrawal

Measure	Pregabalin Then Placebo Participants received 75 milligram (mg) capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first intervention period followed by placebo matched to Pregabalin twice daily from Day 1 to Day 14 in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.	Placebo Then Pregabalin Participants received placebo matched to Pregabalin twice daily from Day 1 to Day 14 in first intervention period followed by Pregabalin 75 mg capsule orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.	Pregabalin + Placebo Then Pregabalin + PF-00489791 Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with placebo matched to PF-00489791 orally once daily from Day 1 to Day 14 in first intervention period. In second intervention period participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 orally once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 orally once daily from Day 4 to Day 14. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.	Pregabalin + PF-00489791 Then Pregabalin + Placebo Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 orally once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 orally once daily from Day 4 to Day 14 in first intervention period. In second intervention period participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with a placebo matched to PF-00489791 orally once daily from Day 1 to Day 14. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.
First Intervention Period (2 Weeks) Adverse Event	1	0	3	2
First Intervention Period (2 Weeks) Withdrawal by Subject	1	0	0	1
First Intervention Period (2 Weeks) Protocol Violation	0	1	0	1
First Intervention Period (2 Weeks) Randomized but not Treated	0	1	0	1
Washout Period (2 Weeks) Withdrawal by Subject	1	0	0	1
Washout Period (2 Weeks) Adverse Event	0	0	0	1
Washout Period (2 Weeks) Lost to Follow-up	0	0	0	1
Washout Period (2 Weeks) Protocol Violation	0	1	0	0
Second Intervention Period (2 Weeks) Protocol Violation	1	0	0	0

Baseline Characteristics

A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia

Baseline characteristics by cohort

Measure	Pregabalin Then Placebo n=16 Participants Participants received 75 milligram (mg) capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first intervention period followed by placebo matched to Pregabalin twice daily from Day 1 to Day 14 in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.	Placebo Then Pregabalin n=13 Participants Participants received placebo matched to Pregabalin twice daily from Day 1 to Day 14 in first intervention period followed by Pregabalin 75 mg capsule orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.	Pregabalin + Placebo Then Pregabalin + PF-00489791 n=20 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with placebo matched to PF-00489791 orally once daily from Day 1 to Day 14 in first intervention period. In second intervention period participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 orally once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 orally once daily from Day 4 to Day 14. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.	Pregabalin + PF-00489791 Then Pregabalin + Placebo n=21 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 orally once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 orally once daily from Day 4 to Day 14 in first intervention period. In second intervention period participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with a placebo matched to PF-00489791 orally once daily from Day 1 to Day 14. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week.	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	27 Participants n=21 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants	14 Participants n=4 Participants	43 Participants n=21 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants	14 Participants n=4 Participants	43 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	27 Participants n=21 Participants

PRIMARY outcome

Timeframe: End of treatment period (included both Week 2 and Week 6)

Population: Full analysis set included all participants who were randomized and had received at least 1 dose of study drug, regardless of whether they had efficacy data and did not have any significant protocol violation. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Pain was assessed by using a daily pain rating scale that consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"), higher scores indicate more pain intensity. Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily. The mean pain score was defined as the mean of the last 7 daily pain ratings scale scores while taking study medication, at end of each treatment period: Period 1 (Week 2) and Period 2 (Week 6), respectively. Mean pain score had a score range of 0 (no pain) to 10 (worst possible pain), higher scores indicate more pain. Cumulative data of mean pain scores at end of treatment for both the periods was calculated and reported in terms of adjusted mean and standard error.

Outcome measures

Measure	Pregabalin + PF-00489791 n=38 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 once daily from Day 4 to Day 14 in first or second intervention period.	Pregabalin n=59 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period.	Placebo n=25 Participants Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period.
Mean Pain Score on Daily Pain Rating Scale (DPRS)	4.32 units on a scale Standard Error 0.343	4.22 units on a scale Standard Error 0.253	5.57 units on a scale Standard Error 0.451

SECONDARY outcome

Timeframe: End of treatment period (included both Week 2 and Week 6)

Population: Full analysis set included all participants who were randomized and had received at least 1 dose of study drug, regardless of whether they had efficacy data and did not have any significant protocol violation. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

The PGIC is a participant-rated instrument that measures change in the participants' overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse), lower scores indicated more improvement. PGIC was evaluated using 3 categories: improvement (scores 1-3), no change (score 4), and worsening (scores 5-7). In this outcome measure percentage of participants with categories: improved, no change and worsening, based on PGIC score were reported. Cumulative data at end of treatment for both the periods (Period 1 [Week 2] and Period 2 [Week6]) was calculated and reported.

Outcome measures

Measure	Pregabalin + PF-00489791 n=31 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 once daily from Day 4 to Day 14 in first or second intervention period.	Pregabalin n=54 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period.	Placebo n=23 Participants Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period.
Percentage of Participants With Patient Global Impression of Change (PGIC) Score Improved	77.42 percentage of participants	77.78 percentage of participants	39.13 percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGIC) Score No Change	16.13 percentage of participants	18.52 percentage of participants	43.48 percentage of participants
Percentage of Participants With Patient Global Impression of Change (PGIC) Score Worse	6.45 percentage of participants	3.70 percentage of participants	17.39 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Full analysis set included all participants who were randomized and had received at least 1 dose of study drug, regardless of whether they had efficacy data and did not have any significant protocol violation. Here, "Number Analyzed" signifies the number of participants who were evaluable at specified time points for each arm, respectively.

Participants marked intensity of the pain on a scale, ranging from 0 millimeters (mm) = no pain to 100 mm = worst possible pain, where higher scores indicate more pain.

Outcome measures

Measure	Pregabalin + PF-00489791 n=38 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 once daily from Day 4 to Day 14 in first or second intervention period.	Pregabalin n=60 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period.	Placebo n=25 Participants Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period.
Pain Visual Analogue Scale (VAS) at Baseline and Week 4 Baseline	66.48 mm Standard Deviation 10.64	65.92 mm Standard Deviation 14.32	67.92 mm Standard Deviation 16.37
Pain Visual Analogue Scale (VAS) at Baseline and Week 4 Week 4	60.88 mm Standard Deviation 22.42	63.79 mm Standard Deviation 14.33	55.92 mm Standard Deviation 22.22

SECONDARY outcome

Timeframe: End of treatment period (included both Week 2 and Week 6)

Population: Full analysis set included all participants who were randomized and had received at least 1 dose of study drug, regardless of whether they had efficacy data and did not have any significant protocol violation. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Participant rated 10-item questionnaire to evaluate different symptoms of neuropathic pain (spontaneous pain like [item 1 to 3]: burning, squeezing, pressure; painful attack like [item 4 to 5]: electric shock, stabbing; pain provoked on [item 6 to 8]: light touching, pressure, contact with something cold; abnormal sensations like [item 9 to 10]: pins and needles, tingling). Each item was rated on an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity of pain). Total NPSI scale ranged from 0 (no pain) to 100 (maximum pain). Higher scores indicate a greater intensity of pain. Cumulative data of NPSI scale at end of treatment for both the periods (Period 1 [Week 2] and Period 2 [Week 6]) was calculated and reported in terms of adjusted mean and standard error.

Outcome measures

Measure	Pregabalin + PF-00489791 n=35 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 once daily from Day 4 to Day 14 in first or second intervention period.	Pregabalin n=55 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period.	Placebo n=24 Participants Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period.
Neuropathic Pain Symptom Inventory (NPSI)	25.71 units on a scale Standard Error 3.134	25.87 units on a scale Standard Error 2.168	35.25 units on a scale Standard Error 5.148

SECONDARY outcome

Timeframe: Baseline up to Week 7

Population: Safety analysis set included all participants who were randomized and had received at least 1 dose of study medication.

Vital signs abnormalities included sitting, standing: systolic, diastolic blood pressure and heart rate. Clinical significance was judged by investigator.

Outcome measures

Measure	Pregabalin + PF-00489791 n=38 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 once daily from Day 4 to Day 14 in first or second intervention period.	Pregabalin n=61 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period.	Placebo n=26 Participants Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period.
Number of Participants With Clinically Significant Vital Signs Abnormalities	0 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 7

Population: Safety analysis set included all participants who were randomized and had received at least 1 dose of study medication.

Criteria for ECG abnormalities: Maximum QTc (corrected QT) interval, QTcB (Bazett's correction formula) and QTcF (Fridericia's correction formula): 450 to less than (<) 480 milliseconds (msec), 480 to <500 msec and greater than equal to (>=) 500 msec; Maximum QTc interval increase from baseline: >=30 to <60 and >=60 (msec); PR interval: >=300 msec and percent change >=25 or 50 percent; QRS complex: percent change >=25 or 50 percent. Clinical significance was judged by investigator.

Outcome measures

Measure	Pregabalin + PF-00489791 n=38 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 once daily from Day 4 to Day 14 in first or second intervention period.	Pregabalin n=61 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period.	Placebo n=26 Participants Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 7

Population: Safety analysis set included all participants who were randomized and had received at least 1 dose of study medication. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Criteria for hematology abnormalities included Hemoglobin: <0.8*lower limit of normal (LLN) and hematocrit: <0.8*LLN. Clinical significance was judged by investigator.

Outcome measures

Measure	Pregabalin + PF-00489791 n=37 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 once daily from Day 4 to Day 14 in first or second intervention period.	Pregabalin n=60 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period.	Placebo n=26 Participants Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period.
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 7

Population: Safety analysis set included all participants who were randomized and had received at least 1 dose of study medication. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Criteria for clinical chemistry abnormalities included total bilirubin: greater than (>) 1.5*upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase: >3.0*ULN; total protein, albumin: <0.8*LLN or >1.2*ULN; blood urea nitrogen, creatinine: >1.3*ULN; uric acid: >1.2*ULN; sodium: <0.95*LLN or >1.05*ULN; potassium, chloride, calcium: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN. Clinical significance was judged by investigator.

Outcome measures

Measure	Pregabalin + PF-00489791 n=37 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 once daily from Day 4 to Day 14 in first or second intervention period.	Pregabalin n=60 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period.	Placebo n=26 Participants Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period.
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 7

Population: Safety analysis set included all participants who were randomized and had received at least 1 dose of study medication. Here "Overall Number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Urinalysis abnormalities criteria included: urine specific gravity: <1.003 to >1.030; urine pH: <4.5 to >8; urine glucose, urine ketones, urine proteins, urine blood/hemoglobin: >=1. Clinical significance was judged by investigator.

Outcome measures

Measure	Pregabalin + PF-00489791 n=37 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 once daily from Day 4 to Day 14 in first or second intervention period.	Pregabalin n=60 Participants Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period.	Placebo n=26 Participants Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period.
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis	0 Participants	0 Participants	0 Participants

Adverse Events

Pregabalin + PF-00489791

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Pregabalin

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pregabalin + PF-00489791 n=38 participants at risk Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 once daily from Day 4 to Day 14 in first or second intervention period.	Pregabalin n=61 participants at risk Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period.	Placebo n=26 participants at risk Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period.
General disorders Chest discomfort	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.

Other adverse events

Measure	Pregabalin + PF-00489791 n=38 participants at risk Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 once daily from Day 4 to Day 14 in first or second intervention period.	Pregabalin n=61 participants at risk Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period.	Placebo n=26 participants at risk Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period.
Blood and lymphatic system disorders Blood disorder	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Ear and labyrinth disorders Tinnitus	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Eye disorders Lacrimation increased	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Eye disorders Vision blurred	5.3% 2/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Eye disorders Visual impairment	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Gastrointestinal disorders Constipation	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	7.9% 3/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	6.6% 4/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Gastrointestinal disorders Dry mouth	5.3% 2/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Gastrointestinal disorders Dyspepsia	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Gastrointestinal disorders Faecal incontinence	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Gastrointestinal disorders Flatulence	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Gastrointestinal disorders Gastritis	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.3% 2/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Gastrointestinal disorders Lip blister	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Gastrointestinal disorders Nausea	5.3% 2/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
General disorders Drug withdrawal syndrome	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
General disorders Chest pain	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
General disorders Fatigue	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	8.2% 5/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
General disorders Gait disturbance	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
General disorders Oedema	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
General disorders Oedema peripheral	5.3% 2/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
General disorders Pain	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Immune system disorders Seasonal allergy	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Infections and infestations Anorectal infection	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Infections and infestations Laryngitis	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Infections and infestations Tooth abscess	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Infections and infestations Upper respiratory tract infection	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Infections and infestations Urinary tract infection	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Infections and infestations Viral infection	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Injury, poisoning and procedural complications Contusion	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Investigations Blood pressure decreased	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Investigations Blood pressure increased	5.3% 2/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Investigations Electrocardiogram QT prolonged	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Investigations Weight increased	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Metabolism and nutrition disorders Increased appetite	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	7.9% 3/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Joint swelling	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Muscle spasms	7.9% 3/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	4.9% 3/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Muscle twitching	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	7.9% 3/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Aphasia	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	4.9% 3/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Balance disorder	5.3% 2/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Burning sensation	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Disturbance in attention	5.3% 2/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Dizziness	18.4% 7/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	14.8% 9/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Dizziness postural	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Headache	7.9% 3/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	6.6% 4/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	7.7% 2/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Hyperaesthesia	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Lethargy	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Memory impairment	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Mental impairment	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Paraesthesia	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Sciatica	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Somnolence	5.3% 2/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	9.8% 6/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Speech disorder	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Nervous system disorders Syncope	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Psychiatric disorders Agitation	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Psychiatric disorders Anxiety	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Psychiatric disorders Disorientation	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Psychiatric disorders Insomnia	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Psychiatric disorders Libido decreased	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Psychiatric disorders Nervousness	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Psychiatric disorders Withdrawal syndrome	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Renal and urinary disorders Hypertonic bladder	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Renal and urinary disorders Nephrolithiasis	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Renal and urinary disorders Nocturia	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Reproductive system and breast disorders Penis disorder	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Reproductive system and breast disorders Testicular pain	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Sinus congestion	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Surgical and medical procedures Sinus operation	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Vascular disorders Flushing	2.6% 1/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
Vascular disorders Hot flush	0.00% 0/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.

Additional Information

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Results disclosure agreements

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

Restriction type: OTHER