Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus

A Multicenter, Randomized, Evaluator-masked, Parallel-group, Non-treatment-controlled Study Followed by an Open-label Study to Evaluate Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01584843

Enrollment

Registered

2012-04-25

Start date

2012-05-31

Completion date

2014-06-30

Last updated

2015-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Strabismus

Keywords

Neuromuscular Agents, Strabismus, Botulinum Toxin Type A

Brief summary

Primary objective is to evaluate the efficacy of single-dose treatment with GSK1358820 compared with non-treatment in patients with strabismus based on angles of strabismus in the primary position.

Detailed description

Primary objective is to evaluate the efficacy of single-dose treatment with GSK1358820 compared with non-treatment in patients with strabismus based on angles of strabismus in the primary position. Secondary objective is to evaluate the efficacy and safety of repeated-dose treatment with GSK1358820 in patients with strabismus.

Interventions

DRUGGSK1358820

IM injection of Botulinum Toxin Type A

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

\<At the start of screening period\> * Paralytic or concomitant strabismus. Subjects with paralytic strabismus will be eligible for inclusion only if paralysis has persisted for at least 3 months and strabismus has been developed at one eye * Horizontal deviations (esotropia or exotropia) * Strabismus with the (absolute) strabismus angles at both distance and near of primary position \>-10 PD and \<50 PD * Age\>-12 years at the time of giving informed consent * The subject has to be capable of giving written informed consent of their own will. For subjects aged less than 20 years, the subject and his/her legally acceptable representative (person in parental authority or guardian) have to give written informed consent * Either sex. Males have to agree to practice contraception during the study period. Females of child-bearing potential will be eligible for inclusion in this study. However, they have to have negative pregnancy test both at the screening visit and just before initial injection and agree to practice reliable methods of contraception * QTc \<450 msec; for patients with Bundle Branch Block, QTc \<480 msec based on average QTc value of triplicate ECGs \<At the start of treatment period \> * Strabismus with the (absolute) strabismus angles at both distance and near of primary position \>-10 PD and \<50 PD * ALT at the screening visit \<2 x ULN and alkaline phosphatase and bilirubin \<-1.5 x ULN

Exclusion criteria

\<At the start of screening period\> * Secondary strabismus caused by prior surgical recession of the antagonist in past surgical treatment of strabismus * Strabismus due to abnormal innervations * Strabismus with thyroid-associated ophthalmopathy * Strabismus with strong motor limitation of extraocular muscles * Mechanical limitations of ocular movement due to periorbital disease or due to past surgical treatment other than strabismus * Blepharoptosis * Conjunctival pathology * Systemic neuromuscular junction dysfunction * Systemic neuromuscular disease * Past treatment with botulinum toxin * Planned injections of botulinum toxin for other indication(s) or for cosmetic purpose during the study period * Known hypersensitivity to any of the drugs to be used in the study or history of allergy * Treatment with antibiotics with neuromuscular junction inhibitory action such as aminoglycosides, polypeptides, tetracyclines and lincomycins, except those contained in topical antibacterial formulations * Treatment with muscle relaxants or drugs with muscle relaxant action * Chronic respiratory disorder * Severe muscle weakness or atrophy * Angle-closure glaucoma or its predisposing factors * Severe cardiac, hepatic or renal impairment. The severity refers to Grade 3 according to the Classification of the Severity of Adverse Experiences (MHLW PAB/SD Notification No. 80, dated 29 June 1992). * Surgical operation or hospitalization to be needed during the study period * Female subjects who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study period * Participation in another clinical study within 6 months prior to enrollment in this study or planned participation in another clinical study after enrollment in this study * Psychiatric disorder or impairment of intellectual function that may affect the subject's ability to give informed consent or to comply with the trial procedures * History of alcohol dependence or drug abuse * Subjects whom the investigator (or sub-investigator) considers ineligible for the study

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)	Baseline and Week 4 of the FTP	The strabismus angle in the primary position was measured using the alternative prism cover test (APCT). The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 meters \[m\]) and the near-view strabismus angle (measured at a distance of 33 centimeters \[cm\]). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 4 minus the value at Baseline.

Secondary

Measure	Time frame	Description
Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP	The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for the observed cases for the change in the strabismus angle in the primary position from Baseline at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)	The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP	Weeks 1 and 4 of the FTP	The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The absolute values of the strabismus angle in the primary position at Week 1 and Week 4 of the FTP were summarized for observed cases without imputation of missing values.
Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP	The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The absolute values of the strabismus angle in the primary position were summarized for observed cases at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups).
Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)	The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period.
Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP	Baseline and Weeks 1 and 4 of the FTP	The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for the percent change from Baseline in the strabismus angle in the primary position at Week 1and Week 4 after the initial injection in the FTP. Percent change from Baseline in the strabismus angle was calculated as: absolute angle (\[strabismus angle at Baseline minus strabismus angle after the final injection\] divided by the absolute strabismus angle at Baseline) multiplied by 100.
Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 of the FTP	The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for percent change from Baseline in the strabismus angle in the primary position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in non-treatment groups; up to a maximum of 52 weeks of the FTP). Percent change from Baseline in the strabismus angle was calculated as: (absolute angle \[strabismus angle at Baseline minus the strabismus angle after the final injection\] divided by the absolute strabismus angle at Baseline) multiplied by
Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC)	Baseline and Week 1 of the FTP	The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 1minus the value at Baseline.
Duration of Effect	Up to Week 48 after the final injection of the FTP (up to Study Week 52)	Duration of effect is defined as the number of days after the final injection of the FTP (after randomization in the non-treatment groups) until the date of the first recording of a value smaller than 50% in percent correction compared to the maximum change in the strabismus angle in the primary position. The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Percent correction compared to the maximum change in the strabismus angle was calculated as: (absolute angle \[strabismus angle at Baseline minus the strabismus angle after injection\]/absolute angle \[strabismus angle at Baseline minus the strabismus angle at maximum change\]) multiplied by 100.
Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 1 and Week 4 of the FTP	The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline.
Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Weeks 1, 4, 8, 12, 16, 20, and 24 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP)	The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline.
Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)	The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure.
Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Baseline and Weeks 1 and 4 of the FTP	The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP)	The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)	The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure.
Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)	The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Percent change from Baseline in the strabismus angle was calculated as: (absolute angle \[strabismus angle at Baseline minus the strabismus angle after the final injection\] divided by the absolute strabismus angle at Baseline) multiplied by 100.

Countries

Japan

Participant flow

Recruitment details

The study consisted of a Screening Period (1-2 weeks), the First Treatment Period (12-52 weeks), and the Second Treatment Period (24 weeks). In this summary, data are presented for participants who completed Week 24 of the First Treatment Period.

Pre-assignment details

A total of 41 participants with horizontal strabismus meeting the selection criteria were divided into two strata in terms of the mean of the distant-view strabismus angle and the near-view strabismus angle in the primary position: \>=10 prism dioptre (PD) to \<20 PD as Strata 1 and \>=20 PD to \<50 PD as Strata 2.

Participants by arm

Arm	Count
Non-treatment, Then GSK1358820 Participants (par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD or with a BSA \>=20 PD and \<50 PD received no treatment from the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U), 2.5 U, or 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.	13
GSK1358820 1.25 U Par with a BSA \>=10 PD and \<20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.	4
GSK1358820 2.5 U Par with a BSA \>=10 PD and \<20 PD or with a BSA \>=20 PD and \<50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.	13
GSK1358820 5.0 U Par with a BSA \>=20 PD and \<50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.	11
Total	41

Withdrawals & dropouts

Period	Reason	FG002	FG005
First Treatment Period	Adverse Event	1	0
First Treatment Period	Met Protocol-defined Stopping Criteria	0	1
First Treatment Period	Protocol Violation	0	1
Second Treatment Period	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Non-treatment, Then GSK1358820	GSK1358820 1.25 U	GSK1358820 2.5 U	GSK1358820 5.0 U	Total
Age, Continuous	43.5 Years STANDARD_DEVIATION 23.67	19.8 Years STANDARD_DEVIATION 9.07	51.4 Years STANDARD_DEVIATION 22.78	49.0 Years STANDARD_DEVIATION 21.79	45.1 Years STANDARD_DEVIATION 23.04
Race/Ethnicity, Customized Asian - Japanese Heritage	13 Participants	4 Participants	13 Participants	11 Participants	41 Participants
Sex: Female, Male Female	7 Participants	3 Participants	7 Participants	5 Participants	22 Participants
Sex: Female, Male Male	6 Participants	1 Participants	6 Participants	6 Participants	19 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	1 / 13	8 / 13	1 / 4	6 / 13	6 / 11
serious Total, serious adverse events	0 / 13	0 / 13	0 / 4	1 / 13	0 / 11

Outcome results

Primary

Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)

The strabismus angle in the primary position was measured using the alternative prism cover test (APCT). The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 meters \[m\]) and the near-view strabismus angle (measured at a distance of 33 centimeters \[cm\]). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 4 minus the value at Baseline.

Time frame: Baseline and Week 4 of the FTP

Population: Full Analysis Set (FAS1) Population: all participants who were randomized and had at least one post-Baseline efficacy assessment. Values were summarized for OC of the FTP without imputation of missing values. Only those participants available at the specified time points were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)	2.33 prism dioptre	Standard Deviation 6.602
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)	-7.50 prism dioptre	Standard Deviation 7.141
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)	-3.75 prism dioptre	Standard Deviation 2.475
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)	-0.55 prism dioptre	Standard Deviation 2.291
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)	-13.40 prism dioptre	Standard Deviation 15.105
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)	-17.27 prism dioptre	Standard Deviation 15.476

p-value: 0.09195% CI: [-21.81, 2.14]Fisher LSD method

p-value: 0.33895% CI: [-20.39, 8.23]Fisher LSD method

p-value: 0.52495% CI: [-9.83, 17.33]Fisher LSD method

p-value: 0.03195% CI: [-24.46, -1.24]Fisher LSD method

p-value: 0.00595% CI: [-28.06, -5.38]Fisher LSD method

p-value: 0.4995% CI: [-15.21, 7.47]Fisher LSD method

Secondary

Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP

Time frame: Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP

Population: FAS1 Population

Arm	Measure	Group	Value (MEAN)	Dispersion
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	8.00 prism dioptre	Standard Deviation 1.732
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	9.33 prism dioptre	Standard Deviation 4.041
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	11.67 prism dioptre	Standard Deviation 4.041
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	13.33 prism dioptre	Standard Deviation 8.737
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	9.50 prism dioptre	Standard Deviation 4.95
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	9.50 prism dioptre	Standard Deviation 4.95
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	8.00 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	9.00 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	11.00 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	11.00 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	9.00 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	9.00 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	11.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	7.50 prism dioptre	Standard Deviation 5.323
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	14.00 prism dioptre	Standard Deviation 12.49
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	9.25 prism dioptre	Standard Deviation 7.182
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	10.17 prism dioptre	Standard Deviation 10.797
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	12.50 prism dioptre	Standard Deviation 10.966
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	10.38 prism dioptre	Standard Deviation 8.138
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	7.50 prism dioptre	Standard Deviation 6.137
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	10.67 prism dioptre	Standard Deviation 12.897
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	14.33 prism dioptre	Standard Deviation 12.662
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	12.00 prism dioptre	Standard Deviation 12.53
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	10.13 prism dioptre	Standard Deviation 9.313
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	8.00 prism dioptre	Standard Deviation 10.966
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	10.00 prism dioptre	Standard Deviation 6.481
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	NA prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	NA prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	NA prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	18.25 prism dioptre	Standard Deviation 6.01
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	17.75 prism dioptre	Standard Deviation 1.061
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	21.00 prism dioptre	Standard Deviation 20.809
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	14.00 prism dioptre	Standard Deviation 0
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	12.00 prism dioptre	Standard Deviation 4.243
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	NA prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	NA prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	NA prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	NA prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	NA prism dioptre	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	27.50 prism dioptre	Standard Deviation 15.199
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	24.85 prism dioptre	Standard Deviation 12.985
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	26.10 prism dioptre	Standard Deviation 10.501
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	31.13 prism dioptre	Standard Deviation 17.731
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	28.50 prism dioptre	Standard Deviation 12.684
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	27.36 prism dioptre	Standard Deviation 11.775
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	30.10 prism dioptre	Standard Deviation 12.577
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	30.75 prism dioptre	Standard Deviation 12.639
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	28.38 prism dioptre	Standard Deviation 15.617
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	32.13 prism dioptre	Standard Deviation 15.644
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	31.63 prism dioptre	Standard Deviation 14.739
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	22.60 prism dioptre	Standard Deviation 14.261
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	21.85 prism dioptre	Standard Deviation 11.626
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	24.14 prism dioptre	Standard Deviation 10.633
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	23.50 prism dioptre	Standard Deviation 9.031
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	24.93 prism dioptre	Standard Deviation 12.654
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	21.70 prism dioptre	Standard Deviation 14.442
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	23.64 prism dioptre	Standard Deviation 12.877
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	17.40 prism dioptre	Standard Deviation 17.98
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	23.43 prism dioptre	Standard Deviation 14.243
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	22.90 prism dioptre	Standard Deviation 12.03
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	14.20 prism dioptre	Standard Deviation 21.953
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	21.21 prism dioptre	Standard Deviation 9.309
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	23.57 prism dioptre	Standard Deviation 11.638
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	22.38 prism dioptre	Standard Deviation 9.837
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	24.55 prism dioptre	Standard Deviation 10.289
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	24.44 prism dioptre	Standard Deviation 15.562
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	24.69 prism dioptre	Standard Deviation 12.587
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	25.38 prism dioptre	Standard Deviation 14.665
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	23.00 prism dioptre	Standard Deviation 13.72
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	23.00 prism dioptre	Standard Deviation 12.186
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	20.95 prism dioptre	Standard Deviation 18.57
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	21.50 prism dioptre	Standard Deviation 14.193
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	26.25 prism dioptre	Standard Deviation 16.466
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	15.73 prism dioptre	Standard Deviation 17.934
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	24.31 prism dioptre	Standard Deviation 18.225
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	22.85 prism dioptre	Standard Deviation 17.626
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	12.91 prism dioptre	Standard Deviation 16.386
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	24.69 prism dioptre	Standard Deviation 11.065

Secondary

Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP

Time frame: Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)

Population: FAS2 population.

Arm	Measure	Group	Value (MEAN)	Dispersion
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 8, n=2, 1, 2, 6, 3, 0	17.00 prism dioptre	Standard Deviation 11.314
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 20, n=2, 1, 2, 6, 3, 0	16.50 prism dioptre	Standard Deviation 10.607
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 24, n=1, 1, 2, 6, 3, 0	20.50 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 12, n=2, 1, 2, 6, 3, 1	16.50 prism dioptre	Standard Deviation 10.607
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 4, n=2, 1, 2, 6, 3, 1	12.50 prism dioptre	Standard Deviation 7.778
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 16, n=1, 1, 2, 6, 3, 0	24.00 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 1, n=2, 1, 2, 6, 3, 1	15.00 prism dioptre	Standard Deviation 12.728
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 8, n=2, 1, 2, 6, 3, 0	11.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 24, n=1, 1, 2, 6, 3, 0	12.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 1, n=2, 1, 2, 6, 3, 1	13.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 4, n=2, 1, 2, 6, 3, 1	11.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 16, n=1, 1, 2, 6, 3, 0	12.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 20, n=2, 1, 2, 6, 3, 0	12.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 12, n=2, 1, 2, 6, 3, 1	15.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 24, n=1, 1, 2, 6, 3, 0	16.25 prism dioptre	Standard Deviation 4.596
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 1, n=2, 1, 2, 6, 3, 1	8.00 prism dioptre	Standard Deviation 2.828
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 4, n=2, 1, 2, 6, 3, 1	9.00 prism dioptre	Standard Deviation 1.414
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 12, n=2, 1, 2, 6, 3, 1	17.00 prism dioptre	Standard Deviation 0
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 20, n=2, 1, 2, 6, 3, 0	16.25 prism dioptre	Standard Deviation 3.182
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 8, n=2, 1, 2, 6, 3, 0	18.50 prism dioptre	Standard Deviation 7.778
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 16, n=1, 1, 2, 6, 3, 0	19.00 prism dioptre	Standard Deviation 0.707
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 4, n=2, 1, 2, 6, 3, 1	22.92 prism dioptre	Standard Deviation 10.646
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 1, n=2, 1, 2, 6, 3, 1	18.08 prism dioptre	Standard Deviation 10.097
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 8, n=2, 1, 2, 6, 3, 0	21.83 prism dioptre	Standard Deviation 12.356
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 12, n=2, 1, 2, 6, 3, 1	24.00 prism dioptre	Standard Deviation 9.69
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 16, n=1, 1, 2, 6, 3, 0	27.42 prism dioptre	Standard Deviation 11.222
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 20, n=2, 1, 2, 6, 3, 0	26.75 prism dioptre	Standard Deviation 13.171
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 24, n=1, 1, 2, 6, 3, 0	27.33 prism dioptre	Standard Deviation 9.621
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 20, n=2, 1, 2, 6, 3, 0	28.83 prism dioptre	Standard Deviation 15.543
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 8, n=2, 1, 2, 6, 3, 0	20.83 prism dioptre	Standard Deviation 10.867
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 16, n=1, 1, 2, 6, 3, 0	25.00 prism dioptre	Standard Deviation 11.456
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 1, n=2, 1, 2, 6, 3, 1	23.00 prism dioptre	Standard Deviation 15.395
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 4, n=2, 1, 2, 6, 3, 1	19.00 prism dioptre	Standard Deviation 11.822
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 12, n=2, 1, 2, 6, 3, 1	23.17 prism dioptre	Standard Deviation 11.514
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 24, n=1, 1, 2, 6, 3, 0	28.50 prism dioptre	Standard Deviation 14.807
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 8, n=2, 1, 2, 6, 3, 0	NA prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 16, n=1, 1, 2, 6, 3, 0	NA prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 4, n=2, 1, 2, 6, 3, 1	16.00 prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 20, n=2, 1, 2, 6, 3, 0	NA prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 1, n=2, 1, 2, 6, 3, 1	13.00 prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 12, n=2, 1, 2, 6, 3, 1	18.00 prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 24, n=1, 1, 2, 6, 3, 0	NA prism dioptre	—

Secondary

Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP

Time frame: Weeks 1 and 4 of the FTP

Population: FAS1 Population

Arm	Measure	Group	Value (MEAN)	Dispersion
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	17.67 prism dioptre	Standard Deviation 2.754
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	18.50 prism dioptre	Standard Deviation 7.794
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	9.25 prism dioptre	Standard Deviation 7.182
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	7.50 prism dioptre	Standard Deviation 6.137
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	12.00 prism dioptre	Standard Deviation 1.414
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	24.00 prism dioptre	Standard Deviation 18.358
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	32.05 prism dioptre	Standard Deviation 9.385
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	33.20 prism dioptre	Standard Deviation 9.855
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	14.20 prism dioptre	Standard Deviation 21.953
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	17.15 prism dioptre	Standard Deviation 17.645
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	18.00 prism dioptre	Standard Deviation 18.126
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	15.55 prism dioptre	Standard Deviation 16.09

Secondary

Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP

The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP)

Population: FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=0, 0, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=0, 0, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=0, 0, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=0, 0, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=0, 0, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=0, 1, 0, 0, 1, 3	2.0 Scores on a scale	Standard Deviation 2.65
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	1.0 Scores on a scale	Standard Deviation 1.41
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=0, 0, 0, 0, 1, 3	2.0 Scores on a scale	Standard Deviation 2.65
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=0, 1, 0, 0, 1, 3	2.0 Scores on a scale	Standard Deviation 2.65
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=0, 1, 0, 0, 1, 3	2.3 Scores on a scale	Standard Deviation 2.31
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=0, 1, 0, 0, 1, 3	2.3 Scores on a scale	Standard Deviation 2.31
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	1.0 Scores on a scale	Standard Deviation 2.83
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=0, 1, 0, 0, 1, 3	2.3 Scores on a scale	Standard Deviation 2.31
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=0, 1, 0, 0, 1, 3	2.0 Scores on a scale	Standard Deviation 2.65
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=0, 1, 0, 0, 1, 3	2.3 Scores on a scale	Standard Deviation 2.31
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=0, 1, 0, 0, 1, 3	2.0 Scores on a scale	Standard Deviation 2.65
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=0, 1, 0, 0, 1, 3	1.7 Scores on a scale	Standard Deviation 3.06
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=0, 1, 0, 0, 1, 3	2.3 Scores on a scale	Standard Deviation 2.31

Secondary

Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP

Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)

Population: FAS2 Population

Secondary

Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP

Time frame: Baseline and Weeks 1 and 4 of the FTP

Arm	Measure	Group	Value (MEAN)	Dispersion
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	0.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	0.8 Scores on a scale	Standard Deviation 1.71
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	1.0 Scores on a scale	Standard Deviation 2.83

Secondary

Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP

The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for the observed cases for the change in the strabismus angle in the primary position from Baseline at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP

Population: FAS1 Population

Arm	Measure	Group	Value (MEAN)	Dispersion
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	-5.00 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	-5.75 prism dioptre	Standard Deviation 1.768
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	-5.75 prism dioptre	Standard Deviation 1.768
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	-4.00 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	-2.00 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-6.83 prism dioptre	Standard Deviation 3.329
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	-8.17 prism dioptre	Standard Deviation 2.566
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	-2.83 prism dioptre	Standard Deviation 6.788
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	-2.00 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	-4.00 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	-2.00 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	-4.50 prism dioptre	Standard Deviation 2.291
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	-4.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	-7.50 prism dioptre	Standard Deviation 6.245
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	-5.75 prism dioptre	Standard Deviation 8.18
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-7.50 prism dioptre	Standard Deviation 7.141
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	-5.00 prism dioptre	Standard Deviation 7.439
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	-4.88 prism dioptre	Standard Deviation 10.103
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	-4.63 prism dioptre	Standard Deviation 8.845
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	-7.33 prism dioptre	Standard Deviation 11.579
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	-5.17 prism dioptre	Standard Deviation 11.751
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	-3.33 prism dioptre	Standard Deviation 13.503
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	-2.83 prism dioptre	Standard Deviation 12.332
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	-1.00 prism dioptre	Standard Deviation 14
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	-1.33 prism dioptre	Standard Deviation 13.796
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	-4.67 prism dioptre	Standard Deviation 13.65
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	NA prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	NA prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	NA prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	NA prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	2.50 prism dioptre	Standard Deviation 9.899
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	NA prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	NA prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-3.75 prism dioptre	Standard Deviation 8.132
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	5.83 prism dioptre	Standard Deviation 22.115
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	2.00 prism dioptre	Standard Deviation 2.828
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	NA prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	-1.75 prism dioptre	Standard Deviation 3.889
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	NA prism dioptre	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	-6.21 prism dioptre	Standard Deviation 4.091
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	-1.50 prism dioptre	Standard Deviation 3.629
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	-11.15 prism dioptre	Standard Deviation 8.307
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	-3.40 prism dioptre	Standard Deviation 2.679
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	-2.00 prism dioptre	Standard Deviation 7.382
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-11.90 prism dioptre	Standard Deviation 5.092
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	-7.65 prism dioptre	Standard Deviation 4.09
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	-8.90 prism dioptre	Standard Deviation 5.934
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	-5.63 prism dioptre	Standard Deviation 4.191
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	-6.50 prism dioptre	Standard Deviation 5.99
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	-2.38 prism dioptre	Standard Deviation 2.056
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	-1.00 prism dioptre	Standard Deviation 4.546
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	-4.75 prism dioptre	Standard Deviation 4.213
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	-9.21 prism dioptre	Standard Deviation 7.521
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	-6.00 prism dioptre	Standard Deviation 6.933
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	-8.31 prism dioptre	Standard Deviation 8.422
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	-6.29 prism dioptre	Standard Deviation 8.401
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	-6.86 prism dioptre	Standard Deviation 9.335
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	-5.50 prism dioptre	Standard Deviation 9.363
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	-16.35 prism dioptre	Standard Deviation 20.033
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	-7.00 prism dioptre	Standard Deviation 11.206
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-13.15 prism dioptre	Standard Deviation 15.324
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	-8.85 prism dioptre	Standard Deviation 10.588
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	-6.79 prism dioptre	Standard Deviation 9.725
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	-6.00 prism dioptre	Standard Deviation 6.811
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	-7.65 prism dioptre	Standard Deviation 8.573
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	-8.38 prism dioptre	Standard Deviation 15.784
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-19.55 prism dioptre	Standard Deviation 16.378
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	-9.94 prism dioptre	Standard Deviation 10.722
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	-9.94 prism dioptre	Standard Deviation 12.486
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	-10.31 prism dioptre	Standard Deviation 16.722
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	-11.60 prism dioptre	Standard Deviation 16.244
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	-12.95 prism dioptre	Standard Deviation 13.15
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	-13.50 prism dioptre	Standard Deviation 16.074
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	-10.28 prism dioptre	Standard Deviation 12.171
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	-10.28 prism dioptre	Standard Deviation 11.514
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	-22.36 prism dioptre	Standard Deviation 14.063
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	-9.25 prism dioptre	Standard Deviation 14.378
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	-10.19 prism dioptre	Standard Deviation 14.909

Secondary

Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)

Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)

Population: FAS2 Population: all participants who were included in the FAS1 Population, received reinjection of the investigational product, and had at least one efficacy assessment after the reinjection

Arm	Measure	Group	Value (MEAN)	Dispersion
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 1, n=2, 1, 2, 6, 3, 1	-2.75 prism dioptre	Standard Deviation 12.374
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 16, n=1, 1, 2, 6, 3, 0	6.00 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 4, n=2, 1, 2, 6, 3, 1	-5.25 prism dioptre	Standard Deviation 7.425
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 24, n=1, 1, 2, 6, 3, 0	2.50 prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 8, n=2, 1, 2, 6, 3, 0	-0.75 prism dioptre	Standard Deviation 10.96
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 20, n=2, 1, 2, 6, 3, 0	-1.25 prism dioptre	Standard Deviation 10.253
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 12, n=2, 1, 2, 6, 3, 1	-1.25 prism dioptre	Standard Deviation 10.253
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 4, n=2, 1, 2, 6, 3, 1	-3.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 12, n=2, 1, 2, 6, 3, 1	1.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 8, n=2, 1, 2, 6, 3, 0	-3.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 16, n=1, 1, 2, 6, 3, 0	-2.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 1, n=2, 1, 2, 6, 3, 1	-1.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 24, n=1, 1, 2, 6, 3, 0	-2.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 20, n=2, 1, 2, 6, 3, 0	-2.00 prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 8, n=2, 1, 2, 6, 3, 0	2.75 prism dioptre	Standard Deviation 11.667
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 4, n=2, 1, 2, 6, 3, 1	-6.75 prism dioptre	Standard Deviation 5.303
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 1, n=2, 1, 2, 6, 3, 1	-7.75 prism dioptre	Standard Deviation 1.061
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 16, n=1, 1, 2, 6, 3, 0	3.25 prism dioptre	Standard Deviation 4.596
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 20, n=2, 1, 2, 6, 3, 0	0.50 prism dioptre	Standard Deviation 7.071
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 12, n=2, 1, 2, 6, 3, 1	1.25 prism dioptre	Standard Deviation 3.889
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 24, n=1, 1, 2, 6, 3, 0	0.50 prism dioptre	Standard Deviation 0.707
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 12, n=2, 1, 2, 6, 3, 1	-10.17 prism dioptre	Standard Deviation 7.421
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 1, n=2, 1, 2, 6, 3, 1	-16.08 prism dioptre	Standard Deviation 9.641
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 4, n=2, 1, 2, 6, 3, 1	-11.25 prism dioptre	Standard Deviation 9.01
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 8, n=2, 1, 2, 6, 3, 0	-12.33 prism dioptre	Standard Deviation 13.717
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 16, n=1, 1, 2, 6, 3, 0	-6.75 prism dioptre	Standard Deviation 8.413
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 20, n=2, 1, 2, 6, 3, 0	-7.42 prism dioptre	Standard Deviation 9.308
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 24, n=1, 1, 2, 6, 3, 0	-6.83 prism dioptre	Standard Deviation 7.387
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 8, n=2, 1, 2, 6, 3, 0	-10.00 prism dioptre	Standard Deviation 3.122
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 4, n=2, 1, 2, 6, 3, 1	-11.83 prism dioptre	Standard Deviation 1.756
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 24, n=1, 1, 2, 6, 3, 0	-2.33 prism dioptre	Standard Deviation 4.752
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 1, n=2, 1, 2, 6, 3, 1	-7.83 prism dioptre	Standard Deviation 7.006
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 20, n=2, 1, 2, 6, 3, 0	-2.00 prism dioptre	Standard Deviation 6.083
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 12, n=2, 1, 2, 6, 3, 1	-7.67 prism dioptre	Standard Deviation 2.517
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 16, n=1, 1, 2, 6, 3, 0	-5.83 prism dioptre	Standard Deviation 3.819
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 24, n=1, 1, 2, 6, 3, 0	NA prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 16, n=1, 1, 2, 6, 3, 0	NA prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 8, n=2, 1, 2, 6, 3, 0	NA prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 4, n=2, 1, 2, 6, 3, 1	-6.50 prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 20, n=2, 1, 2, 6, 3, 0	NA prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 1, n=2, 1, 2, 6, 3, 1	-9.50 prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)	Week 12, n=2, 1, 2, 6, 3, 1	-4.50 prism dioptre	—

Secondary

Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC)

Time frame: Baseline and Week 1 of the FTP

Population: FAS1 Population

Arm	Measure	Value (MEAN)	Dispersion
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC)	1.50 prism dioptre	Standard Deviation 1.323
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC)	-5.75 prism dioptre	Standard Deviation 8.18
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC)	8.83 prism dioptre	Standard Deviation 19.902
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC)	-1.70 prism dioptre	Standard Deviation 3.285
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC)	-16.35 prism dioptre	Standard Deviation 20.033
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC)	-19.73 prism dioptre	Standard Deviation 11.376

Secondary

Duration of Effect

Duration of effect is defined as the number of days after the final injection of the FTP (after randomization in the non-treatment groups) until the date of the first recording of a value smaller than 50% in percent correction compared to the maximum change in the strabismus angle in the primary position. The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Percent correction compared to the maximum change in the strabismus angle was calculated as: (absolute angle \[strabismus angle at Baseline minus the strabismus angle after injection\]/absolute angle \[strabismus angle at Baseline minus the strabismus angle at maximum change\]) multiplied by 100.

Time frame: Up to Week 48 after the final injection of the FTP (up to Study Week 52)

Population: FAS1 Population

Arm	Measure	Value (MEDIAN)
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Duration of Effect	113.0 Days
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Duration of Effect	138.0 Days
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Duration of Effect	27.0 Days
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Duration of Effect	113.5 Days
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Duration of Effect	80.0 Days
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Duration of Effect	84.0 Days

Secondary

Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP

The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for the percent change from Baseline in the strabismus angle in the primary position at Week 1and Week 4 after the initial injection in the FTP. Percent change from Baseline in the strabismus angle was calculated as: absolute angle (\[strabismus angle at Baseline minus strabismus angle after the final injection\] divided by the absolute strabismus angle at Baseline) multiplied by 100.

Time frame: Baseline and Weeks 1 and 4 of the FTP

Population: FAS1 Population

Arm	Measure	Group	Value (MEAN)	Dispersion
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	9.77 Percent change in prism dioptre	Standard Deviation 8.491
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	13.50 Percent change in prism dioptre	Standard Deviation 36.745
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	-35.98 Percent change in prism dioptre	Standard Deviation 48.46
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-47.98 Percent change in prism dioptre	Standard Deviation 42.069
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	68.00 Percent change in prism dioptre	Standard Deviation 136.601
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-22.55 Percent change in prism dioptre	Standard Deviation 10.112
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	-5.33 Percent change in prism dioptre	Standard Deviation 9.956
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-2.32 Percent change in prism dioptre	Standard Deviation 7.337
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	-56.91 Percent change in prism dioptre	Standard Deviation 67.224
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-47.19 Percent change in prism dioptre	Standard Deviation 51.238
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	-61.28 Percent change in prism dioptre	Standard Deviation 37.603
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-52.40 Percent change in prism dioptre	Standard Deviation 46.823

Secondary

Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP

The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for percent change from Baseline in the strabismus angle in the primary position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in non-treatment groups; up to a maximum of 52 weeks of the FTP). Percent change from Baseline in the strabismus angle was calculated as: (absolute angle \[strabismus angle at Baseline minus the strabismus angle after the final injection\] divided by the absolute strabismus angle at Baseline) multiplied by

Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 of the FTP

Population: FAS1 Population

Arm	Measure	Group	Value (MEAN)	Dispersion
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	-28.90 Percent change in prism dioptre	Standard Deviation 15.431
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	-50.07 Percent change in prism dioptre	Standard Deviation 9.697
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	-15.40 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	-38.50 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-42.80 Percent change in prism dioptre	Standard Deviation 19.128
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	-39.75 Percent change in prism dioptre	Standard Deviation 19.87
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	-15.40 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	-15.40 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	-30.80 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	-30.80 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	-21.03 Percent change in prism dioptre	Standard Deviation 43.107
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	-39.75 Percent change in prism dioptre	Standard Deviation 19.87
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	-30.80 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	-13.97 Percent change in prism dioptre	Standard Deviation 74.899
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	-18.23 Percent change in prism dioptre	Standard Deviation 83.395
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	-27.77 Percent change in prism dioptre	Standard Deviation 85.545
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	-30.13 Percent change in prism dioptre	Standard Deviation 62.986
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	-31.23 Percent change in prism dioptre	Standard Deviation 44.523
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-47.98 Percent change in prism dioptre	Standard Deviation 42.069
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	-28.93 Percent change in prism dioptre	Standard Deviation 55.046
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	-35.98 Percent change in prism dioptre	Standard Deviation 48.46
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	-3.80 Percent change in prism dioptre	Standard Deviation 84.778
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	-46.10 Percent change in prism dioptre	Standard Deviation 72.788
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	-48.43 Percent change in prism dioptre	Standard Deviation 35.871
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	-1.43 Percent change in prism dioptre	Standard Deviation 86.222
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	-30.80 Percent change in prism dioptre	Standard Deviation 71.776
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	24.40 Percent change in prism dioptre	Standard Deviation 68.872
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	-8.30 Percent change in prism dioptre	Standard Deviation 22.627
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	NA Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	NA Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	NA Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	NA Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	NA Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	NA Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	NA Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	NA Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	47.17 Percent change in prism dioptre	Standard Deviation 151.828
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-18.00 Percent change in prism dioptre	Standard Deviation 47.235
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	15.40 Percent change in prism dioptre	Standard Deviation 21.779
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	-13.32 Percent change in prism dioptre	Standard Deviation 13.777
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-38.96 Percent change in prism dioptre	Standard Deviation 20.351
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	-24.69 Percent change in prism dioptre	Standard Deviation 14.03
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	-6.78 Percent change in prism dioptre	Standard Deviation 14.954
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	-19.65 Percent change in prism dioptre	Standard Deviation 20.539
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	-37.64 Percent change in prism dioptre	Standard Deviation 27.691
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	-8.63 Percent change in prism dioptre	Standard Deviation 7.602
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	-21.60 Percent change in prism dioptre	Standard Deviation 17.29
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	-30.50 Percent change in prism dioptre	Standard Deviation 23.971
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	-8.20 Percent change in prism dioptre	Standard Deviation 15.849
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	-11.10 Percent change in prism dioptre	Standard Deviation 24.612
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	-21.75 Percent change in prism dioptre	Standard Deviation 18.746
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	-22.00 Percent change in prism dioptre	Standard Deviation 19.92
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	-20.21 Percent change in prism dioptre	Standard Deviation 29.986
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	-23.81 Percent change in prism dioptre	Standard Deviation 30.638
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	-25.30 Percent change in prism dioptre	Standard Deviation 35.381
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	-27.75 Percent change in prism dioptre	Standard Deviation 28.362
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	-32.40 Percent change in prism dioptre	Standard Deviation 34.61
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	-24.39 Percent change in prism dioptre	Standard Deviation 30.858
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	-30.91 Percent change in prism dioptre	Standard Deviation 25.39
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	-20.59 Percent change in prism dioptre	Standard Deviation 23.19
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	-21.09 Percent change in prism dioptre	Standard Deviation 22.844
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	-56.91 Percent change in prism dioptre	Standard Deviation 67.224
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	-27.16 Percent change in prism dioptre	Standard Deviation 28.721
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-46.56 Percent change in prism dioptre	Standard Deviation 51.832
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	-21.53 Percent change in prism dioptre	Standard Deviation 27.576
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 12, n=3, 4, 2, 10, 10, 10	-38.02 Percent change in prism dioptre	Standard Deviation 34.387
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 8, n=3, 4, 2, 10, 10, 10	-41.62 Percent change in prism dioptre	Standard Deviation 44.03
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 20, n=2, 4, 0, 7, 9, 9	-31.97 Percent change in prism dioptre	Standard Deviation 29.371
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 40, n=1, 3, 0, 4, 7, 8	-29.48 Percent change in prism dioptre	Standard Deviation 33.356
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 4, n=3, 4, 2, 10, 10, 11	-57.80 Percent change in prism dioptre	Standard Deviation 46.56
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 44, n=1, 3, 0, 4, 7, 8	-26.38 Percent change in prism dioptre	Standard Deviation 32.674
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 36, n=1, 3, 0, 4, 7, 8	-24.15 Percent change in prism dioptre	Standard Deviation 36.602
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 32, n=1, 3, 0, 4, 7, 8	-28.08 Percent change in prism dioptre	Standard Deviation 28.243
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 24, n=1, 3, 0, 5, 8, 9	-29.84 Percent change in prism dioptre	Standard Deviation 31.502
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 48, n=1, 3, 0, 4, 7, 8	-28.09 Percent change in prism dioptre	Standard Deviation 24.167
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 28, n=1, 3, 0, 4, 7, 8	-31.00 Percent change in prism dioptre	Standard Deviation 41.524
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 1, n=3, 4, 3, 10, 10, 11	-66.98 Percent change in prism dioptre	Standard Deviation 40.186
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP	Week 16, n=2, 4, 2, 9, 10, 10	-34.80 Percent change in prism dioptre	Standard Deviation 39.312

Secondary

Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP

Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)

Population: FAS2 Population

Arm	Measure	Group	Value (MEAN)	Dispersion
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 1, n=2, 1, 2, 6, 3, 1	-16.20 Percent change in prism dioptre	Standard Deviation 70.004
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 16, n=1, 1, 2, 6, 3, 0	33.30 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 4, n=2, 1, 2, 6, 3, 1	-30.00 Percent change in prism dioptre	Standard Deviation 42.426
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 24, n=1, 1, 2, 6, 3, 0	13.90 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 8, n=2, 1, 2, 6, 3, 0	-4.85 Percent change in prism dioptre	Standard Deviation 61.872
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 20, n=2, 1, 2, 6, 3, 0	-7.65 Percent change in prism dioptre	Standard Deviation 57.912
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 12, n=2, 1, 2, 6, 3, 1	-7.65 Percent change in prism dioptre	Standard Deviation 57.912
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 4, n=2, 1, 2, 6, 3, 1	-21.40 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 12, n=2, 1, 2, 6, 3, 1	7.10 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 8, n=2, 1, 2, 6, 3, 0	-21.40 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 16, n=1, 1, 2, 6, 3, 0	-14.30 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 1, n=2, 1, 2, 6, 3, 1	-7.10 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 24, n=1, 1, 2, 6, 3, 0	-14.30 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 20, n=2, 1, 2, 6, 3, 0	-14.30 Percent change in prism dioptre	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 8, n=2, 1, 2, 6, 3, 0	27.45 Percent change in prism dioptre	Standard Deviation 80.822
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 4, n=2, 1, 2, 6, 3, 1	-39.95 Percent change in prism dioptre	Standard Deviation 23.829
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 1, n=2, 1, 2, 6, 3, 1	-49.85 Percent change in prism dioptre	Standard Deviation 5.586
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 16, n=1, 1, 2, 6, 3, 0	25.00 Percent change in prism dioptre	Standard Deviation 35.355
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 20, n=2, 1, 2, 6, 3, 0	9.00 Percent change in prism dioptre	Standard Deviation 47.093
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 12, n=2, 1, 2, 6, 3, 1	11.35 Percent change in prism dioptre	Standard Deviation 27.506
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 24, n=1, 1, 2, 6, 3, 0	2.70 Percent change in prism dioptre	Standard Deviation 3.818
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 12, n=2, 1, 2, 6, 3, 1	-29.87 Percent change in prism dioptre	Standard Deviation 21.927
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 1, n=2, 1, 2, 6, 3, 1	-46.75 Percent change in prism dioptre	Standard Deviation 26.774
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 4, n=2, 1, 2, 6, 3, 1	-33.33 Percent change in prism dioptre	Standard Deviation 27.466
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 8, n=2, 1, 2, 6, 3, 0	-33.95 Percent change in prism dioptre	Standard Deviation 32.783
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 16, n=1, 1, 2, 6, 3, 0	-20.08 Percent change in prism dioptre	Standard Deviation 23.559
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 20, n=2, 1, 2, 6, 3, 0	-23.57 Percent change in prism dioptre	Standard Deviation 27.185
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 24, n=1, 1, 2, 6, 3, 0	-19.68 Percent change in prism dioptre	Standard Deviation 21.456
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 8, n=2, 1, 2, 6, 3, 0	-35.10 Percent change in prism dioptre	Standard Deviation 14.224
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 4, n=2, 1, 2, 6, 3, 1	-43.13 Percent change in prism dioptre	Standard Deviation 21.925
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 24, n=1, 1, 2, 6, 3, 0	-12.13 Percent change in prism dioptre	Standard Deviation 21.004
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 1, n=2, 1, 2, 6, 3, 1	-30.50 Percent change in prism dioptre	Standard Deviation 26.754
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 20, n=2, 1, 2, 6, 3, 0	-10.97 Percent change in prism dioptre	Standard Deviation 21.594
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 12, n=2, 1, 2, 6, 3, 1	-27.77 Percent change in prism dioptre	Standard Deviation 13.999
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 16, n=1, 1, 2, 6, 3, 0	-20.70 Percent change in prism dioptre	Standard Deviation 12.804
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 24, n=1, 1, 2, 6, 3, 0	NA Percent change in prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 16, n=1, 1, 2, 6, 3, 0	NA Percent change in prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 8, n=2, 1, 2, 6, 3, 0	NA Percent change in prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 4, n=2, 1, 2, 6, 3, 1	-28.90 Percent change in prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 20, n=2, 1, 2, 6, 3, 0	NA Percent change in prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 1, n=2, 1, 2, 6, 3, 1	-42.20 Percent change in prism dioptre	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP	Week 12, n=2, 1, 2, 6, 3, 1	-20.00 Percent change in prism dioptre	—

Secondary

Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP

The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline.

Time frame: Weeks 1, 4, 8, 12, 16, 20, and 24 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP)

Arm	Measure	Group	Value (MEAN)	Dispersion
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 8, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 28, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 36, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 24, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 40, n=0, 0, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 32, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 20, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 44, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 16, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 12, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 48, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 28, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 8, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 16, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 44, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 24, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 36, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 32, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 12, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 20, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 48, n=0, 1, 0, 0, 1, 3	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 40, n=0, 0, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 44, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 36, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 40, n=0, 0, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 48, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 8, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 12, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 16, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 20, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 24, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 28, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 32, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 28, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 8, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 16, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 44, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 40, n=0, 0, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 48, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 32, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 20, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 12, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 36, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 24, n=0, 1, 0, 0, 1, 3	NA Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 28, n=0, 1, 0, 0, 1, 3	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 24, n=0, 1, 0, 0, 1, 3	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 12, n=0, 1, 0, 0, 1, 3	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 32, n=0, 1, 0, 0, 1, 3	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 48, n=0, 1, 0, 0, 1, 3	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 40, n=0, 0, 0, 0, 1, 3	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 16, n=0, 1, 0, 0, 1, 3	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 8, n=0, 1, 0, 0, 1, 3	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 44, n=0, 1, 0, 0, 1, 3	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 20, n=0, 1, 0, 0, 1, 3	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 36, n=0, 1, 0, 0, 1, 3	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 36, n=0, 1, 0, 0, 1, 3	-0.7 Scores on a scale	Standard Deviation 1.15
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 44, n=0, 1, 0, 0, 1, 3	-0.3 Scores on a scale	Standard Deviation 0.58
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 8, n=0, 1, 0, 0, 1, 3	-1.0 Scores on a scale	Standard Deviation 1.73
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 12, n=0, 1, 0, 0, 1, 3	-0.3 Scores on a scale	Standard Deviation 0.58
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 28, n=0, 1, 0, 0, 1, 3	-0.7 Scores on a scale	Standard Deviation 1.15
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 16, n=0, 1, 0, 0, 1, 3	-0.3 Scores on a scale	Standard Deviation 0.58
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	-1.0 Scores on a scale	Standard Deviation 1.41
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 40, n=0, 0, 0, 0, 1, 3	-0.7 Scores on a scale	Standard Deviation 1.15
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 20, n=0, 1, 0, 0, 1, 3	-0.7 Scores on a scale	Standard Deviation 1.15
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 24, n=0, 1, 0, 0, 1, 3	-0.3 Scores on a scale	Standard Deviation 0.58
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 32, n=0, 1, 0, 0, 1, 3	-0.7 Scores on a scale	Standard Deviation 1.15
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	-1.0 Scores on a scale	Standard Deviation 1.15
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP	Week 48, n=0, 1, 0, 0, 1, 3	-0.3 Scores on a scale	Standard Deviation 0.58

Secondary

Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP

The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure.

Time frame: Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)

Population: FAS2 Population

Secondary

Severity of Duction Limitation at Weeks 1 and 4 of the FTP

The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline.

Time frame: Week 1 and Week 4 of the FTP

Arm	Measure	Group	Value (MEAN)	Dispersion
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 1.25 U	Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	0.0 Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=10 PD and <20 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820	Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	NA Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 2.5 U	Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	-1.0 Scores on a scale	—
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 1, n=0, 1, 0, 0, 1, 4	-1.3 Scores on a scale	Standard Deviation 0.96
BSA >=20 PD and <50 PD: GSK1358820 5.0 U	Severity of Duction Limitation at Weeks 1 and 4 of the FTP	Week 4, n=0, 1, 0, 0, 1, 4	-1.0 Scores on a scale	Standard Deviation 1.41

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)

Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP

Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP

Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP

Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP

Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP

Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP

Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP

Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)

Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC)

Duration of Effect

Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP

Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP

Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP

Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP

Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP

Severity of Duction Limitation at Weeks 1 and 4 of the FTP