Trial Outcomes & Findings for A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity (NCT NCT03261167)

Last Updated: 2020-06-02

Results Overview

MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+= Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half of ROM, 2 =More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3= Considerable increase in muscle tone, passive movement difficult and 4= Affected part(s) rigid in flexion or extension. Higher scores= Worst outcome while lower scores= Better outcome.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

124 participants

Primary outcome timeframe

Week 6

Results posted on

2020-06-02

Participant Flow

This was a multicenter study conducted at 40 study centers in Japan, of which 38 centers enrolled participants.

A total of 131 participants were screened of which 7 participants were screen failures \[reason being did not meet inclusion exclusion criteria (6) and withdrew consent (1)\] and finally 124 participants were randomized (63 participants in the GSK1358820 240 units \[U\] group and 61 participants in the GSK1358820 400 U group).

Participant milestones

Participant milestones
Measure	GSK1358820 240 U Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Double Blind(Treatment cyc1,Upto Week48) STARTED	63	61
Double Blind(Treatment cyc1,Upto Week48) COMPLETED	60	57
Double Blind(Treatment cyc1,Upto Week48) NOT COMPLETED	3	4
Open-label(Treatment cycle2,Upto Week48) STARTED	60	57
Open-label(Treatment cycle2,Upto Week48) COMPLETED	58	57
Open-label(Treatment cycle2,Upto Week48) NOT COMPLETED	2	0
Open-label(Treatment cycle3,Upto Week48) STARTED	55	56
Open-label(Treatment cycle3,Upto Week48) COMPLETED	54	55
Open-label(Treatment cycle3,Upto Week48) NOT COMPLETED	1	1
Open-label(Treatment cycle4,Upto Week48) STARTED	43	40
Open-label(Treatment cycle4,Upto Week48) COMPLETED	43	40
Open-label(Treatment cycle4,Upto Week48) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1358820 240 U Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Double Blind(Treatment cyc1,Upto Week48) Adverse Event	0	3
Double Blind(Treatment cyc1,Upto Week48) Withdrawal by Subject	3	1
Open-label(Treatment cycle2,Upto Week48) Protocol defined stopping criteria	1	0
Open-label(Treatment cycle2,Upto Week48) Withdrawal by Subject	1	0
Open-label(Treatment cycle3,Upto Week48) Withdrawal by Subject	1	1

Baseline Characteristics

A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1358820 240 U n=63 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U n=61 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	Total n=124 Participants Total of all reporting groups
Age, Continuous	57.3 Years STANDARD_DEVIATION 10.98 • n=5 Participants	57.1 Years STANDARD_DEVIATION 9.90 • n=7 Participants	57.2 Years STANDARD_DEVIATION 10.42 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	46 Participants n=7 Participants	99 Participants n=5 Participants
Race/Ethnicity, Customized Japanese/East Asian Heritage (AH)/South East AH	63 Participants n=5 Participants	60 Participants n=7 Participants	123 Participants n=5 Participants
Race/Ethnicity, Customized Asian & Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 6

Population: Intent to treat 1 (ITT1) Population comprised of participants who were randomized in the study and who had at least 1 post-baseline efficacy assessment.

Outcome measures

Outcome measures
Measure	GSK1358820 240 U n=63 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U n=61 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Percentage of Participants Who Had Modified Ashworth Scale (MAS) Score Reduced at Least 1 From Baseline in the Elbow Flexors at Week 6	50.8 Percentage of participants	68.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 2, Week 4, Week 6 and Week 12

Population: ITT1 Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).

MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion or extension. Higher scores=worst outcome while lower scores=better outcome.

Outcome measures

Outcome measures
Measure	GSK1358820 240 U n=63 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U n=61 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Elbow Flexion, Week 2, n=63,61	44.4 Percentage of participants	77.0 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Elbow Flexion, Week 4, n=63,61	52.4 Percentage of participants	73.8 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Elbow Flexion, Week 6, n=63,61	50.8 Percentage of participants	68.9 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Elbow Flexion, Week 12, n=63,61	33.3 Percentage of participants	45.9 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Wrist Flexion, Week 2, n=63,61	77.8 Percentage of participants	72.1 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Wrist Flexion, Week 4, n=63,61	82.5 Percentage of participants	73.8 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Wrist Flexion, Week 6, n=63,61	81.0 Percentage of participants	68.9 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Wrist flexion, Week 12, n=63,61	54.0 Percentage of participants	44.3 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Finger Flexion, Week 2, n=63,61	87.3 Percentage of participants	78.7 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Finger Flexion, Week 4, n=63,61	85.7 Percentage of participants	75.4 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Finger Flexion, Week 6, n=63,61	81.0 Percentage of participants	72.1 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Finger Flexion, Week 12, n =63,61	46.0 Percentage of participants	45.9 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Thumb Flexion, Week 2, n=60,54	75.0 Percentage of participants	64.8 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Thumb Flexion, Week 4, n=60,54	71.7 Percentage of participants	64.8 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Thumb Flexion, Week 6, n=60,54	68.3 Percentage of participants	66.7 Percentage of participants
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 Thumb flexion, Week 12,n=60,54	46.7 Percentage of participants	46.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 2, Week 4, Week 6 and Week 12

Population: ITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=x in the category titles).

The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion/extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion/extension. Higher scores=worst outcome while lower scores=better outcome. Baseline was defined as the latest pre-first dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Outcome measures

Outcome measures
Measure	GSK1358820 240 U n=63 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U n=61 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Elbow Flexion, Week 2, n=63,60	-0.59 Scores on a scale Standard Error 0.089	-1.07 Scores on a scale Standard Error 0.102
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Elbow Flexion, Week 4, n=63,59	-0.7 Scores on a scale Standard Error 0.097	-1.12 Scores on a scale Standard Error 0.110
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Elbow Flexion, Week 6, n=63,59	-0.71 Scores on a scale Standard Error 0.107	-1.09 Scores on a scale Standard Error 0.128
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Elbow Flexion, Week 12, n=60,57	-0.35 Scores on a scale Standard Error 0.072	-0.61 Scores on a scale Standard Error 0.101
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Wrist Flexion, Week 2, n=63,60	-1.29 Scores on a scale Standard Error 0.120	-1.21 Scores on a scale Standard Error 0.126
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Wrist Flexion, Week 4, n=63,59	-1.45 Scores on a scale Standard Error 0.122	-1.35 Scores on a scale Standard Error 0.132
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Wrist Flexion, Week 6, n=63,59	-1.29 Scores on a scale Standard Error 0.115	-1.31 Scores on a scale Standard Error 0.136
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Wrist flexion, Week 12, n=60,57	-0.69 Scores on a scale Standard Error 0.097	-0.59 Scores on a scale Standard Error 0.107
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Finger Flexion, Week 2, n=63,60	-1.38 Scores on a scale Standard Error 0.113	-1.28 Scores on a scale Standard Error 0.121
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Finger Flexion, Week 4, n=63,59	-1.49 Scores on a scale Standard Error 0.117	-1.32 Scores on a scale Standard Error 0.130
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Finger Flexion, Week 6, n=63,59	-1.36 Scores on a scale Standard Error 0.118	-1.22 Scores on a scale Standard Error 0.123
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Finger Flexion, Week 12, n=60,57	-0.63 Scores on a scale Standard Error 0.116	-0.59 Scores on a scale Standard Error 0.097
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Thumb Flexion, Week 2, n=60,53	-1.24 Scores on a scale Standard Error 0.123	-0.96 Scores on a scale Standard Error 0.130
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Thumb Flexion, Week 4, n=60,53	-1.29 Scores on a scale Standard Error 0.127	-1.15 Scores on a scale Standard Error 0.138
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Thumb Flexion, Week 6, n=60,53	-1.12 Scores on a scale Standard Error 0.119	-1.10 Scores on a scale Standard Error 0.132
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM]) Thumb flexion, Week 12, n=57,51	-0.69 Scores on a scale Standard Error 0.133	-0.61 Scores on a scale Standard Error 0.144

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 2, Week 4, Week 6 and Week 12

Population: ITT1 Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).

The investigator assessed 4 areas of disability namely hygiene, pain, dressing and limb posture and was graded using the 4-point DAS scale where (0=No functional disability, 1: Mild disability, 2: Moderate disability and 3=Severe disability). The investigator, in consultation with the participant, selected 1 functional disability item from the 4 areas of disability and assessed it as a principal therapeutic target. The maximum possible score was 3 where higher scores indicate severe disability and lowers scores indicate sound functional ability. Baseline value was defined as the latest pre-first dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Outcome measures

Outcome measures
Measure	GSK1358820 240 U n=63 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U n=61 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Change From Baseline in Principal Therapeutic Target of Disability Assessment Scale (DAS) - MMRM up to Week 12 Week 2, n=63,60	-0.34 Scores on scale Standard Error 0.087	-0.59 Scores on scale Standard Error 0.085
Change From Baseline in Principal Therapeutic Target of Disability Assessment Scale (DAS) - MMRM up to Week 12 Week 4, n=63,59	-0.46 Scores on scale Standard Error 0.096	-0.62 Scores on scale Standard Error 0.086
Change From Baseline in Principal Therapeutic Target of Disability Assessment Scale (DAS) - MMRM up to Week 12 Week 6, n=63,59	-0.52 Scores on scale Standard Error 0.081	-0.67 Scores on scale Standard Error 0.078
Change From Baseline in Principal Therapeutic Target of Disability Assessment Scale (DAS) - MMRM up to Week 12 Week 12, n=60,57	-0.35 Scores on scale Standard Error 0.082	-0.63 Scores on scale Standard Error 0.092

SECONDARY outcome

Timeframe: Up to 84 days post first treatment

Population: Safety1 Population. Safety1 Population comprised of all participants who were randomized in the study and who receive study treatment at least once.

An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.

Outcome measures

Outcome measures
Measure	GSK1358820 240 U n=63 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U n=61 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) After 84 Days of First Treatment Any AE	29 Participants	31 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) After 84 Days of First Treatment Any SAE	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety1 Population

Outcome measures

Outcome measures
Measure	GSK1358820 240 U n=63 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U n=61 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Number of Participants With AEs and SAEs-Overall Study Period Any AE	52 Participants	49 Participants
Number of Participants With AEs and SAEs-Overall Study Period Any SAE	6 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety1 Population. This analysis was not planned and data was not collected and captured in the database.

Physical examinations included assessment of lungs, cardiovascular system, and abdominal region (liver and spleen). This analysis was not planned and data was not collected and captured in the database.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety1 Population. Only those participants with data available at the indicated time points were analyzed.

Hematology parameters along with their normal ranges included: basophils (0 to 2 percent), eosinophils (0 to 8 percent), hemoglobin (135 to 175 grams/liter), hematocrit (0.397 to 0.524 proportion of red blood cells in blood), lymphocytes (18 to 49 percent), monocytes (2 to 10 percent), total neutrophils (40 to 75 percent), platelet count (140 to 340 giga cells/liter), red blood cell count (4.3 to 5.7 trillion cells/liter), white blood cell count (3.3 to 9 giga cells/liter), mean corpuscular volume (85 to 102 femtoliters), mean corpuscular hemoglobin (28 to 34 picograms) and reticulocyte count (0.004 to 0.019 percent/ratio). Shift in values relative to normal range as high and low have been presented for categories having non-zero values.

Outcome measures

Outcome measures
Measure	GSK1358820 240 U n=62 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U n=59 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Eosinophils, To high	7 Participants	3 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hemoglobin, To low	5 Participants	5 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hemoglobin, To high	1 Participants	5 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hematocrit, To low	5 Participants	5 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hematocrit, To high	4 Participants	6 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Lymphocytes, To low	11 Participants	11 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Lymphocytes, To high	0 Participants	1 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Mean corpuscle hemoglobin, To low	2 Participants	1 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Mean corpuscle hemoglobin, To high	1 Participants	3 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Mean corpuscle volume, To low	3 Participants	0 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Mean corpuscle volume, To high	1 Participants	2 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Monocytes, To high	0 Participants	4 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Total neutrophils, To low	0 Participants	1 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Total neutrophils, To high	6 Participants	11 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Platelet count, To low	2 Participants	1 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Platelet count, To high	7 Participants	4 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Red blood cell count, To low	2 Participants	2 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Red blood cell count, To high	2 Participants	7 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Reticulocytes, To high	4 Participants	5 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline White blood cell count, To low	0 Participants	1 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline White blood cell count, To high	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety 1 Population. Only those participants with data available at the indicated time points were analyzed.

Clinical chemistry parameters assessed were alkaline phosphatase (100 to 325 international units/liter), alanine amino transferase (5 to 45 international units/liter), aspartate amino transferase (10 to 40 international units/liter), direct bilirubin (0 to 3.42 micromoles/liter), total bilirubin (3.42 to 20.52 micromoles/liter), calcium (2.0958 - 2.5948 millimoles/liter), creatinine (53.924 - 91.936 micromoles/liter), potassium (3.5 - 5 millimoles/liter), sodium (137 - 147 millimoles/liter), total protein (67 - 83 grams/liter), urea/blood urea nitrogen (BUN) \[2.856 - 7.14 millimoles/liter\]. Shift in values relative to normal range as high and low have been presented for categories having non-zero values.

Outcome measures

Outcome measures
Measure	GSK1358820 240 U n=62 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U n=59 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Alkaline Phosphatase, High	5 Participants	6 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Alanine amino transferase, High	8 Participants	6 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Aspartate amino transferase, High	3 Participants	2 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Direct bilirubin, High	1 Participants	2 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Total bilirubin, High	0 Participants	2 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Calcium, Low	0 Participants	1 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatinine, Low	5 Participants	1 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatinine, High	3 Participants	2 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Potassium, Low	1 Participants	1 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Potassium, High	1 Participants	1 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Sodium, Low	5 Participants	2 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Sodium, High	1 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Total protein, Low	11 Participants	14 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Total protein, High	1 Participants	1 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Urea/BUN, Low	2 Participants	3 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Urea/BUN, High	7 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety 1 Population. Only those participants with data available at the indicated time points were analyzed.

Urinalysis parameters assessed were urine occult blood, urine protein . In this dipstick test, occult blood and protein in urine samples were recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.

Outcome measures

Outcome measures
Measure	GSK1358820 240 U n=61 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U n=59 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 4+	0 Participants	0 Participants
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Occult blood, Any increase	11 Participants	11 Participants
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Occult blood, Increase to trace	4 Participants	2 Participants
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Occult blood, Increase to 1+	2 Participants	7 Participants
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Occult blood, Increase to 2+	1 Participants	2 Participants
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Occult blood, Increase to 3+	4 Participants	0 Participants
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Any increase	9 Participants	14 Participants
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to trace	4 Participants	11 Participants
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 1+	4 Participants	2 Participants
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 2+	1 Participants	0 Participants
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 3+	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 12 and Week 48

Population: Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).

Vital sign parameters SBP and DBP were measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. SBP and DBP were measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.

Outcome measures

Outcome measures
Measure	GSK1358820 240 U n=63 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U n=61 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12 and Week 48 SBP, Week 12; n=60, 57	0.8 Millimeters of mercury Standard Deviation 11.29	1.3 Millimeters of mercury Standard Deviation 11.19
Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12 and Week 48 DBP, Week 12; n=60, 57	0.5 Millimeters of mercury Standard Deviation 8.01	0.1 Millimeters of mercury Standard Deviation 10.39
Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12 and Week 48 SBP, Week 48; n=57, 56	-1.6 Millimeters of mercury Standard Deviation 13.85	-1.7 Millimeters of mercury Standard Deviation 14.60
Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12 and Week 48 DBP, Week 48; n=57, 56	-1.8 Millimeters of mercury Standard Deviation 10.01	-1.2 Millimeters of mercury Standard Deviation 11.42

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 12 and Week 48

Population: Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).

Vital sign parameter heart rate was measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. Heart rate was measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.

Outcome measures

Outcome measures
Measure	GSK1358820 240 U n=63 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U n=61 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Change From Baseline in Vital Sign Parameter Heart Rate at Week 12 and Week 48 Week 12; n=60, 57	0.2 Beats per minute Standard Deviation 9.95	2.6 Beats per minute Standard Deviation 8.20
Change From Baseline in Vital Sign Parameter Heart Rate at Week 12 and Week 48 Week 48; n=57, 56	0.5 Beats per minute Standard Deviation 10.05	-0.1 Beats per minute Standard Deviation 9.01

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 12 and Week 48

Population: Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).

Vital sign parameter temperature was measured orally, intra-aurally, or axillary fossa, the participant was instructed to refrain from eating food or drinking beverage within 5 minutes before the measurement. The method for the measurement of body temperature was same throughout the study. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.

Outcome measures

Outcome measures
Measure	GSK1358820 240 U n=63 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles \[cyc\] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.	GSK1358820 400 U n=61 Participants Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis \[B1\], Flexor carpi ulnaris \[B2\]), finger (Flexor digitorum profundus \[C1\], Flexor digitorum superficialis \[C2\]), thumb (Flexor pollicis longus \[D1\], Adductor pollicis \[D2\]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii \[A1\], Brachialis \[A2\], Brachioradialis \[A3\] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Change From Baseline in Vital Sign Parameter Temperature at Week 12 and Week 48 Week 12; n=59, 56	-0.03 Degree Celsius Standard Deviation 0.428	-0.08 Degree Celsius Standard Deviation 0.466
Change From Baseline in Vital Sign Parameter Temperature at Week 12 and Week 48 Week 48; n=57, 56	0.00 Degree Celsius Standard Deviation 0.505	-0.06 Degree Celsius Standard Deviation 0.461

Adverse Events

GSK1358820 240 U (Double Blind-Treatment Cycle 1)

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

GSK1358820 400 U (Double Blind-Treatment Cycle 1)

Serious events: 5 serious events

Other events: 24 other events

Deaths: 1 deaths

GSK1358820 240 U (Open Label-Treatment Cycle 2)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

GSK1358820 400 U (Open labelTreatment Cycle 2)

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

GSK1358820 240 U (Open Label-Treatment Cycle 3)

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

GSK1358820 400 U (Open Label-Treatment Cycle 3)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

GSK1358820 240 U (Open Label-Treatment Cycle 4)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

GSK1358820 400 U (Open Label-Treatment Cycle 4)

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK1358820 240 U (Double Blind-Treatment Cycle 1) n=63 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase.	GSK1358820 400 U (Double Blind-Treatment Cycle 1) n=61 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase.	GSK1358820 240 U (Open Label-Treatment Cycle 2) n=60 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injection in the open-label phase (Treatment cycle 2).	GSK1358820 400 U (Open labelTreatment Cycle 2) n=57 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injection in the open-label phase (Treatment cycle 2).	GSK1358820 240 U (Open Label-Treatment Cycle 3) n=55 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycle 2 and 3 of open-label phase with an interval of 12 weeks between treatments.	GSK1358820 400 U (Open Label-Treatment Cycle 3) n=56 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycles 2 and 3 of open-label phase with an interval of 12 weeks between treatments.	GSK1358820 240 U (Open Label-Treatment Cycle 4) n=43 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycle 2, 3 and 4 of open-label phase with an interval of 12 weeks between treatments.	GSK1358820 400 U (Open Label-Treatment Cycle 4) n=40 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycles 2, 3 and 4 of open-label phase with an interval of 12 weeks between treatments.
Infections and infestations Pneumonia	1.6% 1/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.6% 1/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.8% 1/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Infections and infestations Lung infection	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.7% 1/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Infections and infestations Pyelonephritis	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.8% 1/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Injury, poisoning and procedural complications Ankle fracture	1.6% 1/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.6% 1/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.6% 1/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Nervous system disorders Altered state of consciousness	1.6% 1/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Nervous system disorders Cerebral haemorrhage	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.6% 1/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
General disorders Decreased activity	1.6% 1/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.6% 1/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.8% 1/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	1.6% 1/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Psychiatric disorders Delirium	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.6% 1/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Infections and infestations Cellulitis	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.8% 1/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.8% 1/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Nervous system disorders Cerebral infarction	1.6% 1/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Nervous system disorders Dementia Alzheimer's type	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.6% 1/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Renal and urinary disorders Dysuria	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.6% 1/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).

Other adverse events

Other adverse events
Measure	GSK1358820 240 U (Double Blind-Treatment Cycle 1) n=63 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase.	GSK1358820 400 U (Double Blind-Treatment Cycle 1) n=61 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase.	GSK1358820 240 U (Open Label-Treatment Cycle 2) n=60 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injection in the open-label phase (Treatment cycle 2).	GSK1358820 400 U (Open labelTreatment Cycle 2) n=57 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injection in the open-label phase (Treatment cycle 2).	GSK1358820 240 U (Open Label-Treatment Cycle 3) n=55 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycle 2 and 3 of open-label phase with an interval of 12 weeks between treatments.	GSK1358820 400 U (Open Label-Treatment Cycle 3) n=56 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycles 2 and 3 of open-label phase with an interval of 12 weeks between treatments.	GSK1358820 240 U (Open Label-Treatment Cycle 4) n=43 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycle 2, 3 and 4 of open-label phase with an interval of 12 weeks between treatments.	GSK1358820 400 U (Open Label-Treatment Cycle 4) n=40 participants at risk Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycles 2, 3 and 4 of open-label phase with an interval of 12 weeks between treatments.
Infections and infestations Nasopharyngitis	17.5% 11/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	11.5% 7/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.3% 2/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.8% 1/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	7.3% 4/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	4.7% 2/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	7.5% 3/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Injury, poisoning and procedural complications Fall	4.8% 3/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	11.5% 7/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	6.7% 4/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	8.8% 5/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	5.5% 3/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	5.4% 3/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	4.7% 2/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Injury, poisoning and procedural complications Contusion	1.6% 1/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	6.6% 4/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	5.0% 3/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	5.3% 3/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.8% 1/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.6% 2/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Psychiatric disorders Insomnia	1.6% 1/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	4.9% 3/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Infections and infestations Gingivitis	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.3% 1/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Infections and infestations Acute sinusitis	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Infections and infestations Sinusitis	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Infections and infestations Upper respiratory tract infection	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Infections and infestations Cystitis	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Infections and infestations Oral herpes	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	4.7% 2/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Injury, poisoning and procedural complications Joint swelling	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Injury, poisoning and procedural complications Limb injury	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Immune system disorders Contrast media allergy	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
General disorders Nodule	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Gastrointestinal disorders Stomatitis	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	2.5% 1/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Vascular disorders Hypertension	3.2% 2/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.6% 1/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	4.7% 2/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Immune system disorders Seasonal allergy	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.3% 2/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.6% 2/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.6% 2/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Musculoskeletal and connective tissue disorders Back pain	3.2% 2/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.6% 1/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.6% 2/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.8% 1/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Investigations Alanine aminotransferase increased	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.6% 2/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Investigations Oxygen saturation decreased	3.2% 2/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	4.9% 3/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.6% 2/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Gastrointestinal disorders Dental caries	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.3% 2/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.5% 2/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	1.7% 1/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.5% 2/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Nervous system disorders Parkinsonism	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.5% 2/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Infections and infestations Influenza	4.8% 3/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.3% 2/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	4.9% 3/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.3% 2/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Gastrointestinal disorders Constipation	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	4.9% 3/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	0.00% 0/63 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	3.3% 2/61 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/60 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/57 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/55 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/56 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/43 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).	0.00% 0/40 • Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase. Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER