Trial Outcomes & Findings for Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis (NCT NCT02201524)

NCT ID: NCT02201524

Last Updated: 2016-10-05

Results Overview

PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2016-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.	PF-04965842 200 mg Twice Daily Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Study STARTED	14	15	16	14
Overall Study COMPLETED	12	12	12	10
Overall Study NOT COMPLETED	2	3	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.	PF-04965842 200 mg Twice Daily Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Overall Study Adverse Event	0	2	1	0
Overall Study Insufficient clinical response	1	0	0	0
Overall Study Lost to Follow-up	0	0	2	0
Overall Study No longer meets eligibility criteria	0	0	0	2
Overall Study Protocol Violation	0	0	0	1
Overall Study Withdrawal by Subject	0	0	1	1
Overall Study Other	1	1	0	0

Baseline Characteristics

Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Total n=59 Participants Total of all reporting groups
Age, Continuous	45.4 years STANDARD_DEVIATION 10.8 • n=5 Participants	42.9 years STANDARD_DEVIATION 12.3 • n=7 Participants	42.8 years STANDARD_DEVIATION 11.6 • n=5 Participants	52.1 years STANDARD_DEVIATION 9.7 • n=4 Participants	45.7 years STANDARD_DEVIATION 11.5 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	19 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	8 Participants n=4 Participants	40 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: The modified intent to treat (mITT) analysis set included all randomized participants who received at least 1 dose of the randomized study drug (PF-04965842 or placebo). Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4 Baseline (n= 14, 15, 16, 14)	18.01 units on a scale Standard Deviation 5.507	20.05 units on a scale Standard Deviation 3.993	20.34 units on a scale Standard Deviation 7.089	19.21 units on a scale Standard Deviation 4.426
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4 Change at Week 4 (n= 12, 12, 12, 10)	-13.71 units on a scale Standard Deviation 6.248	-6.61 units on a scale Standard Deviation 7.252	-11.73 units on a scale Standard Deviation 6.658	-13.09 units on a scale Standard Deviation 7.979

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 8

Population: The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 5 (n= 11, 12, 12, 9)	-80.80 percent change Standard Deviation 20.279	-42.62 percent change Standard Deviation 21.228	-58.63 percent change Standard Deviation 16.015	-57.76 percent change Standard Deviation 37.397
Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 6 (n= 11, 11, 10, 10)	-69.15 percent change Standard Deviation 26.871	-39.85 percent change Standard Deviation 28.661	-61.02 percent change Standard Deviation 11.655	-56.94 percent change Standard Deviation 39.558
Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 8 (n= 8, 11, 11, 8)	-61.67 percent change Standard Deviation 29.352	-44.62 percent change Standard Deviation 26.616	-44.28 percent change Standard Deviation 27.486	-48.63 percent change Standard Deviation 35.373
Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 1 (n= 14, 15, 16, 14)	-30.99 percent change Standard Deviation 28.557	-13.68 percent change Standard Deviation 18.527	-23.27 percent change Standard Deviation 18.796	-24.07 percent change Standard Deviation 22.272
Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 2 (n= 14, 14, 13, 12)	-49.09 percent change Standard Deviation 30.153	-26.68 percent change Standard Deviation 25.776	-27.96 percent change Standard Deviation 20.161	-41.54 percent change Standard Deviation 28.779
Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 3 (n= 13, 12, 15, 11)	-73.37 percent change Standard Deviation 22.569	-27.06 percent change Standard Deviation 31.220	-33.96 percent change Standard Deviation 19.793	-53.18 percent change Standard Deviation 33.326
Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 4 (n= 12, 12, 12, 10)	-80.96 percent change Standard Deviation 23.155	-33.59 percent change Standard Deviation 31.574	-57.61 percent change Standard Deviation 21.594	-64.46 percent change Standard Deviation 32.175

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 5, 6, 8

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 Change at Week 1 (n= 14, 15, 16, 14)	-5.46 units on a scale Standard Deviation 4.965	-2.96 units on a scale Standard Deviation 4.306	-5.13 units on a scale Standard Deviation 4.902	-4.79 units on a scale Standard Deviation 4.900
Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 Change at Week 2 (n= 14, 14, 13, 12)	-8.51 units on a scale Standard Deviation 5.860	-5.26 units on a scale Standard Deviation 5.205	-5.80 units on a scale Standard Deviation 4.915	-8.33 units on a scale Standard Deviation 7.103
Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 Change at Week 3 (n= 13, 12, 15, 11)	-12.61 units on a scale Standard Deviation 4.461	-5.38 units on a scale Standard Deviation 7.033	-7.44 units on a scale Standard Deviation 5.824	-10.77 units on a scale Standard Deviation 8.048
Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 Change at Week 5 (n= 11, 12, 12, 9)	-14.17 units on a scale Standard Deviation 6.483	-8.69 units on a scale Standard Deviation 5.314	-11.68 units on a scale Standard Deviation 5.262	-11.77 units on a scale Standard Deviation 8.421
Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 Change at Week 6 (n= 11, 11, 10, 10)	-11.80 units on a scale Standard Deviation 6.678	-8.05 units on a scale Standard Deviation 6.989	-12.00 units on a scale Standard Deviation 4.901	-12.13 units on a scale Standard Deviation 9.576
Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8 Change at Week 8 (n= 8, 11, 11, 8)	-10.75 units on a scale Standard Deviation 6.382	-9.33 units on a scale Standard Deviation 6.745	-8.38 units on a scale Standard Deviation 4.933	-10.04 units on a scale Standard Deviation 8.287

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 8

PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 50 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Week 1 (n= 14, 15, 16, 14)	21.4 percentage of participants Interval 6.1 to 46.6	7.1 percentage of participants Interval 0.4 to 29.7	6.7 percentage of participants Interval 0.3 to 27.9	25.0 percentage of participants Interval 9.0 to 48.4
Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Week 2 (n= 14, 14, 13, 12)	41.7 percentage of participants Interval 18.1 to 68.5	21.4 percentage of participants Interval 6.1 to 46.6	7.1 percentage of participants Interval 0.4 to 29.7	23.1 percentage of participants Interval 6.6 to 49.5
Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Week 3 (n= 13, 12, 15, 11)	90.9 percentage of participants Interval 63.6 to 99.5	23.1 percentage of participants Interval 6.6 to 49.5	25.0 percentage of participants Interval 7.2 to 52.7	46.7 percentage of participants Interval 24.4 to 70.0
Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Week 4 (n= 12, 12, 12, 10)	80.0 percentage of participants Interval 49.3 to 96.3	25.0 percentage of participants Interval 7.2 to 52.7	66.7 percentage of participants Interval 39.1 to 87.7	66.7 percentage of participants Interval 39.1 to 87.7
Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Week 5 (n= 11, 12, 12, 9)	100.0 percentage of participants Interval 71.7 to 100.0	54.5 percentage of participants Interval 27.1 to 80.0	66.7 percentage of participants Interval 39.1 to 87.7	58.3 percentage of participants Interval 31.5 to 81.9
Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Week 6 (n= 11, 11, 10, 10)	70.0 percentage of participants Interval 39.3 to 91.3	45.5 percentage of participants Interval 20.0 to 72.9	81.8 percentage of participants Interval 53.0 to 96.7	60.0 percentage of participants Interval 30.4 to 85.0
Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Week 8 (n= 8, 11, 11, 8)	62.5 percentage of participants Interval 28.9 to 88.9	50.0 percentage of participants Interval 19.3 to 80.7	45.5 percentage of participants Interval 20.0 to 72.9	63.6 percentage of participants Interval 35.0 to 86.5

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 8

PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 75 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 Week 1 (n= 14, 15, 16, 14)	7.1 percentage of participants Interval 0.4 to 29.7	0.0 percentage of participants Interval 0.0 to 19.3	0.0 percentage of participants Interval 0.0 to 18.1	0.0 percentage of participants Interval 0.0 to 17.1
Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 Week 2 (n= 14, 14, 13, 12)	25.0 percentage of participants Interval 7.2 to 52.7	7.1 percentage of participants Interval 0.4 to 29.7	0.0 percentage of participants Interval 0.0 to 19.3	15.4 percentage of participants Interval 2.8 to 41.0
Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 Week 3 (n= 13, 12, 15, 11)	36.4 percentage of participants Interval 13.5 to 65.0	7.7 percentage of participants Interval 0.4 to 31.6	0.0 percentage of participants Interval 0.0 to 22.1	40.0 percentage of participants Interval 19.1 to 64.0
Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 Week 4 (n= 12, 12, 12, 10)	60.0 percentage of participants Interval 30.4 to 85.0	16.7 percentage of participants Interval 3.0 to 43.8	16.7 percentage of participants Interval 3.0 to 43.8	50.0 percentage of participants Interval 24.5 to 75.5
Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 Week 5 (n= 11, 12, 12, 9)	66.7 percentage of participants Interval 34.5 to 90.2	0.0 percentage of participants Interval 0.0 to 23.8	25.0 percentage of participants Interval 7.2 to 52.7	50.0 percentage of participants Interval 24.5 to 75.5
Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 Week 6 (n= 11, 11, 10, 10)	50.0 percentage of participants Interval 22.2 to 77.8	18.2 percentage of participants Interval 3.3 to 47.0	9.1 percentage of participants Interval 0.5 to 36.4	60.0 percentage of participants Interval 30.4 to 85.0
Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8 Week 8 (n= 8, 11, 11, 8)	25.0 percentage of participants Interval 4.6 to 60.0	25.0 percentage of participants Interval 4.6 to 60.0	9.1 percentage of participants Interval 0.5 to 36.4	18.2 percentage of participants Interval 3.3 to 47.0

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)

PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 90 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Week 1 (n= 14, 15, 16, 14)	7.1 percentage of participants Interval 0.4 to 29.7	0.0 percentage of participants Interval 0.0 to 19.3	0.0 percentage of participants Interval 0.0 to 18.1	0.0 percentage of participants Interval 0.0 to 17.1
Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Week 2 (n= 14, 14, 13, 12)	8.3 percentage of participants Interval 0.4 to 33.9	7.1 percentage of participants Interval 0.4 to 29.7	0.0 percentage of participants Interval 0.0 to 19.3	7.7 percentage of participants Interval 0.4 to 31.6
Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Week 3 (n= 13, 12, 15, 11)	36.4 percentage of participants Interval 13.5 to 65.0	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 22.1	13.3 percentage of participants Interval 2.4 to 36.3
Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Week 4 (n= 12, 12, 12, 10)	60.0 percentage of participants Interval 30.4 to 85.0	0.0 percentage of participants Interval 0.0 to 22.1	0.0 percentage of participants Interval 0.0 to 22.1	33.3 percentage of participants Interval 12.3 to 60.9
Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Week 5 (n= 11, 12, 12, 9)	44.4 percentage of participants Interval 16.9 to 74.9	0.0 percentage of participants Interval 0.0 to 23.8	0.0 percentage of participants Interval 0.0 to 22.1	25.0 percentage of participants Interval 7.2 to 52.7
Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Week 6 (n= 11, 11, 10, 10)	30.0 percentage of participants Interval 8.7 to 60.7	0.0 percentage of participants Interval 0.0 to 23.8	0.0 percentage of participants Interval 0.0 to 23.8	20.0 percentage of participants Interval 3.7 to 50.7
Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8 Week 8 (n= 8, 11, 11, 8)	25.0 percentage of participants Interval 4.6 to 60.0	0.0 percentage of participants Interval 0.0 to 31.2	0.0 percentage of participants Interval 0.0 to 23.8	0.0 percentage of participants Interval 0.0 to 23.8

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4, 5, 6, 8

The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions. The severity rating scores (erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S= total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicating more severity. Participants with response of clear and almost clear were reported. 90 percent confidence intervals were calculated using clopper-pearson (exact) method.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 Week 2 (n= 14, 14, 13, 12)	41.7 percentage of participants Interval 18.1 to 68.5	7.1 percentage of participants Interval 0.4 to 29.7	28.6 percentage of participants Interval 10.4 to 54.0	23.1 percentage of participants Interval 6.6 to 49.5
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 Week 8 (n= 8, 11, 11, 8)	37.5 percentage of participants Interval 11.1 to 71.1	25.0 percentage of participants Interval 4.6 to 60.0	27.3 percentage of participants Interval 7.9 to 56.4	45.5 percentage of participants Interval 20.0 to 72.9
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 Week 1 (n= 14, 15, 16, 14)	7.1 percentage of participants Interval 0.4 to 29.7	0.0 percentage of participants Interval 0.0 to 19.3	13.3 percentage of participants Interval 2.4 to 36.3	12.5 percentage of participants Interval 2.3 to 34.4
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 Week 3 (n= 13, 12, 15, 11)	45.5 percentage of participants Interval 20.0 to 72.9	15.4 percentage of participants Interval 2.8 to 41.0	33.3 percentage of participants Interval 12.3 to 60.9	46.7 percentage of participants Interval 24.4 to 70.0
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 Week 4 (n= 12, 12, 12, 10)	70.0 percentage of participants Interval 39.3 to 91.3	16.7 percentage of participants Interval 3.0 to 43.8	41.7 percentage of participants Interval 18.1 to 68.5	58.3 percentage of participants Interval 31.5 to 81.9
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 Week 5 (n= 11, 12, 12, 9)	77.8 percentage of participants Interval 45.0 to 95.9	27.3 percentage of participants Interval 7.9 to 56.4	33.3 percentage of participants Interval 12.3 to 60.9	41.7 percentage of participants Interval 18.1 to 68.5
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8 Week 6 (n= 11, 11, 10, 10)	50.0 percentage of participants Interval 22.2 to 77.8	36.4 percentage of participants Interval 13.5 to 65.0	45.5 percentage of participants Interval 20.0 to 72.9	40.0 percentage of participants Interval 15.0 to 69.6

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8 (early termination)

Population: The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Participants were required to fast 9 hours prior to sampling for lipid profile which included following parameters: low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), cholesterol, triglycerides.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 Triglycerides: Baseline (n= 14, 15, 16, 14)	134.21 milligram per deciliter (mg/dL) Standard Deviation 53.903 • Interval 108.7 to 159.73	116.64 milligram per deciliter (mg/dL) Standard Deviation 47.490 • Interval 94.17 to 139.12	175.00 milligram per deciliter (mg/dL) Standard Deviation 74.971 • Interval 140.91 to 209.09	125.50 milligram per deciliter (mg/dL) Standard Deviation 50.552 • Interval 103.35 to 147.65
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 Baseline: (n= 14, 15. 16, 14)	113.93 milligram per deciliter (mg/dL) Standard Deviation 31.770 • Interval 98.89 to 128.97	119.07 milligram per deciliter (mg/dL) Standard Deviation 24.780 • Interval 107.34 to 130.8	105.27 milligram per deciliter (mg/dL) Standard Deviation 28.632 • Interval 92.25 to 118.29	114.56 milligram per deciliter (mg/dL) Standard Deviation 28.317 • Interval 102.15 to 126.97
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 LDL-C: Change at Week 2 (n= 13, 14, 14, 12)	26.92 milligram per deciliter (mg/dL) Standard Deviation 24.748 • Interval 14.09 to 39.75	-6.31 milligram per deciliter (mg/dL) Standard Deviation 16.825 • Interval -14.62 to 2.01	18.50 milligram per deciliter (mg/dL) Standard Deviation 31.035 • Interval 3.81 to 33.19	3.21 milligram per deciliter (mg/dL) Standard Deviation 25.097 • Interval -8.66 to 15.09
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 LDL-C: Change at Week 4 (n= 12, 12, 12, 10)	15.20 milligram per deciliter (mg/dL) Standard Deviation 30.904 • Interval -2.71 to 33.11	-2.50 milligram per deciliter (mg/dL) Standard Deviation 11.350 • Interval -8.38 to 3.38	26.75 milligram per deciliter (mg/dL) Standard Deviation 26.455 • Interval 13.04 to 40.46	10.17 milligram per deciliter (mg/dL) Standard Deviation 22.143 • Interval -1.31 to 21.65
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 LDL-C: Change at Week 8 (n= 7, 11, 10, 8)	-15.13 milligram per deciliter (mg/dL) Standard Deviation 20.301 • Interval -28.72 to -1.53	7.14 milligram per deciliter (mg/dL) Standard Deviation 20.659 • Interval -8.03 to 22.32	6.00 milligram per deciliter (mg/dL) Standard Deviation 16.529 • Interval -3.03 to 15.03	-3.20 milligram per deciliter (mg/dL) Standard Deviation 12.072 • Interval -10.2 to 3.8
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 HDL-C: Baseline (n= 14, 15, 16, 14)	50.29 milligram per deciliter (mg/dL) Standard Deviation 10.163 • Interval 45.48 to 55.1	52.93 milligram per deciliter (mg/dL) Standard Deviation 12.640 • Interval 46.95 to 58.91	46.47 milligram per deciliter (mg/dL) Standard Deviation 11.230 • Interval 41.36 to 51.57	49.06 milligram per deciliter (mg/dL) Standard Deviation 15.058 • Interval 42.46 to 55.66
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 HDL-C: Change at Week 2 (n= 13, 14, 14, 12)	14.00 milligram per deciliter (mg/dL) Standard Deviation 8.113 • Interval 9.79 to 18.21	-1.54 milligram per deciliter (mg/dL) Standard Deviation 7.881 • Interval -5.43 to 2.36	10.00 milligram per deciliter (mg/dL) Standard Deviation 5.533 • Interval 7.38 to 12.62	10.64 milligram per deciliter (mg/dL) Standard Deviation 9.295 • Interval 6.24 to 15.04
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 HDL-C: Change at Week 4 (n= 12, 12, 12, 10)	12.80 milligram per deciliter (mg/dL) Standard Deviation 10.075 • Interval 6.96 to 18.64	-1.00 milligram per deciliter (mg/dL) Standard Deviation 6.238 • Interval -4.23 to 2.23	9.25 milligram per deciliter (mg/dL) Standard Deviation 6.717 • Interval 5.77 to 12.73	12.25 milligram per deciliter (mg/dL) Standard Deviation 10.437 • Interval 6.84 to 17.66
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 HDL-C: Change at Week 8 (n= 7, 11, 10, 8)	-5.00 milligram per deciliter (mg/dL) Standard Deviation 6.234 • Interval -9.18 to -0.82	-2.43 milligram per deciliter (mg/dL) Standard Deviation 10.737 • Interval -10.31 to 5.46	-2.36 milligram per deciliter (mg/dL) Standard Deviation 2.730 • Interval -3.86 to -0.87	-0.40 milligram per deciliter (mg/dL) Standard Deviation 6.275 • Interval -4.04 to 3.24
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 Cholesterol: Baseline (n= 14, 15, 16, 14)	191.14 milligram per deciliter (mg/dL) Standard Deviation 36.469 • Interval 173.88 to 208.4	195.43 milligram per deciliter (mg/dL) Standard Deviation 30.137 • Interval 181.16 to 209.69	186.80 milligram per deciliter (mg/dL) Standard Deviation 25.741 • Interval 175.09 to 198.51	188.75 milligram per deciliter (mg/dL) Standard Deviation 32.298 • Interval 174.6 to 202.9
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 Cholesterol: Change at Week 2 (n= 13, 14, 14 12)	44.08 milligram per deciliter (mg/dL) Standard Deviation 23.469 • Interval 31.92 to 56.25	-0.77 milligram per deciliter (mg/dL) Standard Deviation 14.800 • Interval -8.08 to 6.55	29.57 milligram per deciliter (mg/dL) Standard Deviation 31.329 • Interval 14.74 to 44.4	21.00 milligram per deciliter (mg/dL) Standard Deviation 34.005 • Interval 4.91 to 37.09
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 Cholesterol: Change at Week 4 (n= 12, 12, 12, 10)	26.40 milligram per deciliter (mg/dL) Standard Deviation 29.220 • Interval 9.46 to 43.34	-3.50 milligram per deciliter (mg/dL) Standard Deviation 20.174 • Interval -13.96 to 6.96	40.08 milligram per deciliter (mg/dL) Standard Deviation 25.062 • Interval 27.09 to 53.08	27.25 milligram per deciliter (mg/dL) Standard Deviation 22.919 • Interval 15.37 to 39.13
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 Cholesterol: Change at Week 8 (n= 7, 11, 10, 8)	-10.88 milligram per deciliter (mg/dL) Standard Deviation 23.991 • Interval -26.94 to 5.19	9.86 milligram per deciliter (mg/dL) Standard Deviation 24.361 • Interval -8.04 to 27.75	7.45 milligram per deciliter (mg/dL) Standard Deviation 14.733 • Interval -0.6 to 15.51	-1.20 milligram per deciliter (mg/dL) Standard Deviation 20.395 • Interval -13.02 to 10.62
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 Triglycerides: Change at Week 2 (n= 13, 14, 14 12)	15.83 milligram per deciliter (mg/dL) Standard Deviation 43.151 • Interval -6.54 to 38.2	35.85 milligram per deciliter (mg/dL) Standard Deviation 49.173 • Interval 11.54 to 60.15	23.79 milligram per deciliter (mg/dL) Standard Deviation 72.638 • Interval -10.59 to 58.17	35.86 milligram per deciliter (mg/dL) Standard Deviation 47.337 • Interval 13.45 to 58.26
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 Triglycerides: Change at Week 4 (n=12, 12, 12, 10)	-7.30 milligram per deciliter (mg/dL) Standard Deviation 44.144 • Interval -32.89 to 18.29	0.67 milligram per deciliter (mg/dL) Standard Deviation 42.470 • Interval -21.35 to 22.68	35.67 milligram per deciliter (mg/dL) Standard Deviation 80.714 • Interval -6.18 to 77.51	24.00 milligram per deciliter (mg/dL) Standard Deviation 66.766 • Interval -10.61 to 58.61
Change From Baseline in Fasting Lipids at Week 2, 4 and 8 Triglycerides: Change at Week 8 (n= 7, 11, 10, 8)	46.50 milligram per deciliter (mg/dL) Standard Deviation 62.198 • Interval 4.84 to 88.16	48.71 milligram per deciliter (mg/dL) Standard Deviation 102.301 • Interval -26.42 to 123.85	41.09 milligram per deciliter (mg/dL) Standard Deviation 68.405 • Interval 3.71 to 78.47	12.20 milligram per deciliter (mg/dL) Standard Deviation 44.434 • Interval -13.56 to 37.96

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8 (early termination)

The ratio of LDL-C/HDL-C was reported.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Change From Baseline in Lipid Ratios at Week 2, 4 and 8 LDL C: HDL C; Change at Week 8 (n=7,11,10, 8)	-0.04 ratio Standard Deviation 0.362 • Interval -0.28 to 0.21	0.37 ratio Standard Deviation 0.381 • Interval 0.09 to 0.65	0.32 ratio Standard Deviation 0.439 • Interval 0.08 to 0.56	-0.07 ratio Standard Deviation 0.324 • Interval -0.26 to 0.12
Change From Baseline in Lipid Ratios at Week 2, 4 and 8 LDL-C: HDL C; Baseline (n= 14,15,16,14)	2.37 ratio Standard Deviation 0.912 • Interval 1.94 to 2.8	2.35 ratio Standard Deviation 0.745 • Interval 2.0 to 2.7	2.39 ratio Standard Deviation 0.915 • Interval 1.98 to 2.81	2.48 ratio Standard Deviation 0.735 • Interval 2.16 to 2.8
Change From Baseline in Lipid Ratios at Week 2, 4 and 8 LDL-C: HDL C; Change at Week 2 (n=13,14,14,12)	-0.03 ratio Standard Deviation 0.367 • Interval -0.22 to 0.16	0.02 ratio Standard Deviation 0.449 • Interval -0.2 to 0.24	-0.05 ratio Standard Deviation 0.593 • Interval -0.33 to 0.23	-0.33 ratio Standard Deviation 0.384 • Interval -0.51 to -0.14
Change From Baseline in Lipid Ratios at Week 2, 4 and 8 LDL C: HDL C; Change at Week 4 (n= 12, 12, 12, 10)	-0.07 ratio Standard Deviation 0.813 • Interval -0.54 to 0.4	0.01 ratio Standard Deviation 0.218 • Interval -0.1 to 0.12	0.11 ratio Standard Deviation 0.552 • Interval -0.17 to 0.4	-0.30 ratio Standard Deviation 0.468 • Interval -0.54 to -0.06

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 8 (early termination)

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Reference range for measurements is 0-0.5 mg/dL and lower limit of detection is less than (\<) 0.015 mg/dL. Any value \<0.015 mg/dL is imputed as 0.0075 mg/dL.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 Baseline (n= 14, 15, 16, 14)	0.4994 mg/dL Standard Deviation 0.43345 • Interval 0.2943 to 0.7046	0.6056 mg/dL Standard Deviation 1.05280 • Interval 0.1074 to 1.1039	0.6718 mg/dL Standard Deviation 0.71527 • Interval 0.3465 to 0.9971	0.3325 mg/dL Standard Deviation 0.28854 • Interval 0.206 to 0.4589
Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 Change at Week 1 (n= 14, 15, 16, 14)	-0.3807 mg/dL Standard Deviation 0.49723 • Interval -0.6161 to -0.1454	-0.1451 mg/dL Standard Deviation 0.37322 • Interval -0.3218 to 0.0315	-0.5495 mg/dL Standard Deviation 0.66033 • Interval -0.8498 to -0.2492	-0.2288 mg/dL Standard Deviation 0.26512 • Interval -0.345 to -0.1127
Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 Change at Week 2 (n= 13, 14, 14, 12)	-0.3374 mg/dL Standard Deviation 0.49736 • Interval -0.5952 to -0.0795	-0.1712 mg/dL Standard Deviation 0.49223 • Interval -0.4145 to 0.0722	-0.4540 mg/dL Standard Deviation 0.80459 • Interval -0.8349 to -0.0732	-0.1783 mg/dL Standard Deviation 0.27518 • Interval -0.3085 to -0.048
Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 Change at Week 3 (n= 12, 12, 15, 11)	-0.2214 mg/dL Standard Deviation 0.48102 • Interval -0.4843 to 0.0415	0.0323 mg/dL Standard Deviation 0.61746 • Interval -0.2879 to 0.3524	1.2447 mg/dL Standard Deviation 5.21627 • Interval -1.4596 to 3.9489	-0.0471 mg/dL Standard Deviation 0.45332 • Interval -0.2532 to 0.1591
Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 Change at Week 4 (n= 11, 12, 12, 10)	-0.0850 mg/dL Standard Deviation 0.63410 • Interval -0.4526 to 0.2826	-0.0284 mg/dL Standard Deviation 0.64387 • Interval -0.3803 to 0.3235	-0.4093 mg/dL Standard Deviation 0.83169 • Interval -0.8405 to 0.0218	0.1162 mg/dL Standard Deviation 0.95838 • Interval -0.3806 to 0.6131
Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8 Change at Week 8 (n= 7, 11, 11, 8)	-0.0081 mg/dL Standard Deviation 0.16782 • Interval -0.1205 to 0.1043	-0.5996 mg/dL Standard Deviation 1.17921 • Interval -1.4656 to 0.2665	-0.2473 mg/dL Standard Deviation 0.94249 • Interval -0.7623 to 0.2678	0.2521 mg/dL Standard Deviation 0.53698 • Interval -0.0413 to 0.5456

SECONDARY outcome

Timeframe: Baseline up to Week 8 (early termination)

Population: The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.

EBV samples were collected and changes from baseline were evaluated by the principal investigator (PI) for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in adverse event (AEs) or required follow-up.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline up to Week 8 (early termination)

Population: The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.

CMV samples were collected and changes from baseline were evaluated by the PI for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in AEs or required follow-up.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline up to Week 8 (early termination)

Population: The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.

HSV DNA samples were collected and changes from baseline were evaluated by the PI for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in AEs or required follow-up.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)

Outcome measures

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 Baseline (n= 14, 15, 16, 14)	72.6 beats per minute (bpm) Standard Deviation 9.64	67.6 beats per minute (bpm) Standard Deviation 7.87	71.8 beats per minute (bpm) Standard Deviation 11.85	72.2 beats per minute (bpm) Standard Deviation 11.54
Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 1 (n= 14, 15, 16, 14)	-4.3 beats per minute (bpm) Standard Deviation 7.43	1.0 beats per minute (bpm) Standard Deviation 6.50	-0.2 beats per minute (bpm) Standard Deviation 8.51	0.0 beats per minute (bpm) Standard Deviation 10.56
Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 2 (n= 13, 13, 14, 10)	-2.8 beats per minute (bpm) Standard Deviation 8.48	2.8 beats per minute (bpm) Standard Deviation 9.97	-4.7 beats per minute (bpm) Standard Deviation 9.39	-2.4 beats per minute (bpm) Standard Deviation 8.50
Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 3 (n= 12, 12, 14, 10)	-2.3 beats per minute (bpm) Standard Deviation 6.88	4.1 beats per minute (bpm) Standard Deviation 15.09	-1.3 beats per minute (bpm) Standard Deviation 10.76	-1.5 beats per minute (bpm) Standard Deviation 11.06
Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 4 (n= 12, 12, 12, 10)	0.5 beats per minute (bpm) Standard Deviation 9.37	-1.3 beats per minute (bpm) Standard Deviation 9.69	-1.3 beats per minute (bpm) Standard Deviation 12.89	-4.7 beats per minute (bpm) Standard Deviation 10.87
Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 5 (n= 11, 12, 12, 9)	7.8 beats per minute (bpm) Standard Deviation 11.11	5.2 beats per minute (bpm) Standard Deviation 12.75	2.7 beats per minute (bpm) Standard Deviation 10.44	-0.8 beats per minute (bpm) Standard Deviation 10.34
Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 6 (n= 11, 12, 12, 10)	4.7 beats per minute (bpm) Standard Deviation 9.15	4.5 beats per minute (bpm) Standard Deviation 12.36	-1.8 beats per minute (bpm) Standard Deviation 11.46	2.4 beats per minute (bpm) Standard Deviation 8.53
Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 8 (n= 14, 14, 13, 13)	-1.2 beats per minute (bpm) Standard Deviation 8.12	0.9 beats per minute (bpm) Standard Deviation 11.96	-0.6 beats per minute (bpm) Standard Deviation 13.87	-5.3 beats per minute (bpm) Standard Deviation 11.29

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 8 (n= 14, 14, 13, 12)	-1.0 respiration per minute (resp/min) Standard Deviation 1.60	-0.3 respiration per minute (resp/min) Standard Deviation 1.49	-0.2 respiration per minute (resp/min) Standard Deviation 2.01	-0.8 respiration per minute (resp/min) Standard Deviation 1.30
Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 Baseline (n= 14, 15, 16, 13)	17.0 respiration per minute (resp/min) Standard Deviation 2.16	16.2 respiration per minute (resp/min) Standard Deviation 1.58	17.1 respiration per minute (resp/min) Standard Deviation 3.67	16.3 respiration per minute (resp/min) Standard Deviation 2.44
Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 1 (n= 14, 15, 16, 13)	-0.3 respiration per minute (resp/min) Standard Deviation 1.60	-0.5 respiration per minute (resp/min) Standard Deviation 1.70	0.9 respiration per minute (resp/min) Standard Deviation 1.98	-0.1 respiration per minute (resp/min) Standard Deviation 0.81
Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 2 (n= 13, 13, 14, 9)	0.7 respiration per minute (resp/min) Standard Deviation 2.65	-0.5 respiration per minute (resp/min) Standard Deviation 1.45	0.4 respiration per minute (resp/min) Standard Deviation 1.71	-0.6 respiration per minute (resp/min) Standard Deviation 1.82
Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 3 (n= 12, 12, 14, 9)	0.2 respiration per minute (resp/min) Standard Deviation 1.56	-0.3 respiration per minute (resp/min) Standard Deviation 0.87	-0.6 respiration per minute (resp/min) Standard Deviation 1.51	-0.4 respiration per minute (resp/min) Standard Deviation 1.69
Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 4 (n= 12, 12, 12, 9)	0.0 respiration per minute (resp/min) Standard Deviation 1.41	0.2 respiration per minute (resp/min) Standard Deviation 2.12	-0.7 respiration per minute (resp/min) Standard Deviation 1.72	-1.2 respiration per minute (resp/min) Standard Deviation 1.75
Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 5 (n= 11, 12, 12, 8)	-0.6 respiration per minute (resp/min) Standard Deviation 1.92	0.1 respiration per minute (resp/min) Standard Deviation 1.45	0.3 respiration per minute (resp/min) Standard Deviation 2.30	-0.9 respiration per minute (resp/min) Standard Deviation 1.78
Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 6 (n= 11, 12, 12, 9)	-0.2 respiration per minute (resp/min) Standard Deviation 1.20	-0.4 respiration per minute (resp/min) Standard Deviation 0.81	0.2 respiration per minute (resp/min) Standard Deviation 1.34	-0.8 respiration per minute (resp/min) Standard Deviation 1.54

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 Baseline (n= 14, 15, 16, 14)	36.57 degree celsius Standard Deviation 0.433	36.49 degree celsius Standard Deviation 0.363	36.59 degree celsius Standard Deviation 0.274	36.67 degree celsius Standard Deviation 0.282
Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 1 (n= 14, 15, 16, 14)	-0.17 degree celsius Standard Deviation 0.271	-0.01 degree celsius Standard Deviation 0.264	-0.03 degree celsius Standard Deviation 0.322	0.00 degree celsius Standard Deviation 0.265
Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 2 (n= 13, 13, 14, 10)	-0.05 degree celsius Standard Deviation 0.273	-0.04 degree celsius Standard Deviation 0.366	-0.22 degree celsius Standard Deviation 0.397	-0.05 degree celsius Standard Deviation 0.509
Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 3 (n= 12, 12, 14, 10)	0.09 degree celsius Standard Deviation 0.501	-0.04 degree celsius Standard Deviation 0.391	-0.21 degree celsius Standard Deviation 0.510	-0.11 degree celsius Standard Deviation 0.287
Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 4 (n= 12, 12, 12, 10)	-0.12 degree celsius Standard Deviation 0.477	-0.07 degree celsius Standard Deviation 0.467	-0.21 degree celsius Standard Deviation 0.362	-0.02 degree celsius Standard Deviation 0.346
Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 5 (n= 11, 12, 12, 9)	0.13 degree celsius Standard Deviation 0.443	0.21 degree celsius Standard Deviation 0.316	0.07 degree celsius Standard Deviation 0.318	0.01 degree celsius Standard Deviation 0.305
Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 6 (n= 10, 12, 12, 10)	0.00 degree celsius Standard Deviation 0.390	0.05 degree celsius Standard Deviation 0.328	-0.00 degree celsius Standard Deviation 0.292	-0.07 degree celsius Standard Deviation 0.269
Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8 Change at Week 8 (n= 14, 14, 13, 13)	0.07 degree celsius Standard Deviation 0.426	0.10 degree celsius Standard Deviation 0.332	-0.01 degree celsius Standard Deviation 0.361	-0.05 degree celsius Standard Deviation 0.326

SECONDARY outcome

Timeframe: Baseline up to Week 8 (early termination)

Population: The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate	0 bpm	0 bpm	0 bpm	0 bpm

SECONDARY outcome

Timeframe: Baseline up to Week 8 (early termination)

Population: The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.

ECG change data was reported as qualitative results, as per change in planned analysis. It was categorized as: normal; abnormal, not clinically significant or abnormal, clinically significant.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters	0 participants	0 participants	0 participants	0 participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

PF-04965842 200 Milligram (mg) Once Daily

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

PF-04965842 400 mg Once Daily

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

PF-04965842 200 mg Twice Daily

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=14 participants at risk Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 participants at risk Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 participants at risk Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.	PF-04965842 200 mg Twice Daily n=14 participants at risk Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
Nervous system disorders Transient ischaemic attack	7.1% 1/14 The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/15 The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/14 The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

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

Measure	PF-04965842 200 mg Twice Daily n=14 Participants Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.	Placebo n=14 Participants Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.	PF-04965842 200 Milligram (mg) Once Daily n=15 Participants Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.	PF-04965842 400 mg Once Daily n=16 Participants Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Diastolic BP: Change at Week 8 (n= 14,14,13,13)	1.4 millimeter of mercury (mmHg) Standard Deviation 9.26	-1.1 millimeter of mercury (mmHg) Standard Deviation 8.12	-0.6 millimeter of mercury (mmHg) Standard Deviation 6.08	1.5 millimeter of mercury (mmHg) Standard Deviation 9.77
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Systolic BP: Baseline (n= 14,15,16,14)	128.0 millimeter of mercury (mmHg) Standard Deviation 11.50	125.4 millimeter of mercury (mmHg) Standard Deviation 11.77	125.5 millimeter of mercury (mmHg) Standard Deviation 11.46	124.7 millimeter of mercury (mmHg) Standard Deviation 12.97
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Systolic BP: Change at Week 1 (n= 14, 15, 16, 14)	2.0 millimeter of mercury (mmHg) Standard Deviation 10.88	-2.1 millimeter of mercury (mmHg) Standard Deviation 9.64	-1.5 millimeter of mercury (mmHg) Standard Deviation 10.94	0.6 millimeter of mercury (mmHg) Standard Deviation 8.87
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Systolic BP: Change at Week 2 (n= 13, 13, 14, 10)	-0.4 millimeter of mercury (mmHg) Standard Deviation 7.68	-0.3 millimeter of mercury (mmHg) Standard Deviation 6.73	-1.6 millimeter of mercury (mmHg) Standard Deviation 9.46	3.9 millimeter of mercury (mmHg) Standard Deviation 8.01
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Systolic BP: Change at Week 3 (n= 12, 12, 14, 10)	-1.0 millimeter of mercury (mmHg) Standard Deviation 13.65	-4.5 millimeter of mercury (mmHg) Standard Deviation 7.09	-3.3 millimeter of mercury (mmHg) Standard Deviation 7.82	6.7 millimeter of mercury (mmHg) Standard Deviation 16.82
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Systolic BP: Change at Week 4 (n= 12, 12, 12, 10)	1.7 millimeter of mercury (mmHg) Standard Deviation 15.44	-2.3 millimeter of mercury (mmHg) Standard Deviation 5.66	-5.8 millimeter of mercury (mmHg) Standard Deviation 12.40	0.2 millimeter of mercury (mmHg) Standard Deviation 7.44
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Systolic BP: Change at Week 5 (n= 11, 12, 12, 9)	2.0 millimeter of mercury (mmHg) Standard Deviation 18.08	-2.9 millimeter of mercury (mmHg) Standard Deviation 9.98	-0.8 millimeter of mercury (mmHg) Standard Deviation 8.29	-0.3 millimeter of mercury (mmHg) Standard Deviation 10.37
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Systolic BP: Change at Week 6 (n= 11, 12, 12, 10)	-0.2 millimeter of mercury (mmHg) Standard Deviation 11.37	-5.7 millimeter of mercury (mmHg) Standard Deviation 8.95	-1.3 millimeter of mercury (mmHg) Standard Deviation 7.99	-2.0 millimeter of mercury (mmHg) Standard Deviation 8.86
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Systolic BP: Change at Week 8 (n= 14, 14, 13, 13)	3.5 millimeter of mercury (mmHg) Standard Deviation 11.49	-2.3 millimeter of mercury (mmHg) Standard Deviation 12.96	-2.1 millimeter of mercury (mmHg) Standard Deviation 9.61	-2.1 millimeter of mercury (mmHg) Standard Deviation 7.12
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Diastolic BP: Baseline (n=14,15,16,14)	79.9 millimeter of mercury (mmHg) Standard Deviation 10.73	77.1 millimeter of mercury (mmHg) Standard Deviation 7.39	76.5 millimeter of mercury (mmHg) Standard Deviation 6.84	77.4 millimeter of mercury (mmHg) Standard Deviation 9.85
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Diastolic BP: Change at Week 1 (n=14,15,16,14)	2.0 millimeter of mercury (mmHg) Standard Deviation 10.02	0.0 millimeter of mercury (mmHg) Standard Deviation 6.88	0.9 millimeter of mercury (mmHg) Standard Deviation 6.97	0.8 millimeter of mercury (mmHg) Standard Deviation 9.99
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Diastolic BP: Change at Week 2 (n=13,13,14,10)	2.5 millimeter of mercury (mmHg) Standard Deviation 6.08	0.6 millimeter of mercury (mmHg) Standard Deviation 8.08	1.5 millimeter of mercury (mmHg) Standard Deviation 8.96	-0.4 millimeter of mercury (mmHg) Standard Deviation 9.13
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Diastolic BP: Change at Week 3 (n=12,12,14,10)	0.3 millimeter of mercury (mmHg) Standard Deviation 10.70	-0.7 millimeter of mercury (mmHg) Standard Deviation 8.17	-0.9 millimeter of mercury (mmHg) Standard Deviation 7.50	1.1 millimeter of mercury (mmHg) Standard Deviation 7.76
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Diastolic BP Change at Week 4 (n=12,12,12,10)	2.4 millimeter of mercury (mmHg) Standard Deviation 9.58	-2.5 millimeter of mercury (mmHg) Standard Deviation 8.21	-2.3 millimeter of mercury (mmHg) Standard Deviation 6.61	1.2 millimeter of mercury (mmHg) Standard Deviation 5.46
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Diastolic BP: Change at Week 5 (n= 11, 12, 12, 9)	1.8 millimeter of mercury (mmHg) Standard Deviation 10.32	0.8 millimeter of mercury (mmHg) Standard Deviation 5.13	0.0 millimeter of mercury (mmHg) Standard Deviation 5.64	0.4 millimeter of mercury (mmHg) Standard Deviation 5.62
Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8 Diastolic BP: Change at Week 6 (n=11,12,12,10)	0.9 millimeter of mercury (mmHg) Standard Deviation 7.49	0.5 millimeter of mercury (mmHg) Standard Deviation 5.91	2.1 millimeter of mercury (mmHg) Standard Deviation 6.36	-2.8 millimeter of mercury (mmHg) Standard Deviation 5.67