Trial Outcomes & Findings for Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus (NCT NCT01584843)

Last Updated: 2015-07-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

41 participants

Primary outcome timeframe

Baseline and Week 4 of the FTP

Results posted on

2015-07-24

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U Par with a BSA \>=10 PD and \<20 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.	BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U Par 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, 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.	BSA >=20 PD and <50 PD: 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.
First Treatment Period STARTED	3	4	3	10	10	11
First Treatment Period COMPLETED	3	4	2	10	10	9
First Treatment Period NOT COMPLETED	0	0	1	0	0	2
Second Treatment Period STARTED	2	1	2	6	3	1
Second Treatment Period COMPLETED	2	1	2	6	3	0
Second Treatment Period NOT COMPLETED	0	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	BSA >=10 PD and <20 PD: GSK1358820 2.5 U Par with a BSA \>=10 PD and \<20 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.	BSA >=20 PD and <50 PD: 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.
First Treatment Period Adverse Event	1	0
First Treatment Period Protocol Violation	0	1
First Treatment Period Met Protocol-defined Stopping Criteria	0	1
Second Treatment Period Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-treatment, Then GSK1358820 n=13 Participants 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.	GSK1358820 1.25 U n=4 Participants 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.	GSK1358820 2.5 U n=13 Participants 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.	GSK1358820 5.0 U n=11 Participants 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.	Total n=41 Participants Total of all reporting groups
Age, Continuous	43.5 Years STANDARD_DEVIATION 23.67 • n=5 Participants	19.8 Years STANDARD_DEVIATION 9.07 • n=7 Participants	51.4 Years STANDARD_DEVIATION 22.78 • n=5 Participants	49.0 Years STANDARD_DEVIATION 21.79 • n=4 Participants	45.1 Years STANDARD_DEVIATION 23.04 • n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	22 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	19 Participants n=21 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	13 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants	11 Participants n=4 Participants	41 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=3 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=4 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=2 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=10 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=10 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=11 Participants 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.
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	-7.50 prism dioptre Standard Deviation 7.141	-3.75 prism dioptre Standard Deviation 2.475	-0.55 prism dioptre Standard Deviation 2.291	-13.40 prism dioptre Standard Deviation 15.105	-17.27 prism dioptre Standard Deviation 15.476

SECONDARY outcome

Timeframe: Baseline and Week 1 of the FTP

Population: FAS1 Population

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=3 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=4 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=3 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=10 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=10 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=11 Participants 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.
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	-5.75 prism dioptre Standard Deviation 8.180	8.83 prism dioptre Standard Deviation 19.902	-1.70 prism dioptre Standard Deviation 3.285	-16.35 prism dioptre Standard Deviation 20.033	-19.73 prism dioptre Standard Deviation 11.376

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=3 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=4 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=3 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=10 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=10 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=11 Participants 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.
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	-5.75 prism dioptre Standard Deviation 8.180	5.83 prism dioptre Standard Deviation 22.115	-11.15 prism dioptre Standard Deviation 8.307	-16.35 prism dioptre Standard Deviation 20.033	-22.36 prism dioptre Standard Deviation 14.063
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	-7.50 prism dioptre Standard Deviation 7.141	-3.75 prism dioptre Standard Deviation 8.132	-11.90 prism dioptre Standard Deviation 5.092	-13.15 prism dioptre Standard Deviation 15.324	-19.55 prism dioptre Standard Deviation 16.378
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	-7.50 prism dioptre Standard Deviation 6.245	2.00 prism dioptre Standard Deviation 2.828	-8.90 prism dioptre Standard Deviation 5.934	-8.85 prism dioptre Standard Deviation 10.588	-13.50 prism dioptre Standard Deviation 16.074
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	-5.00 prism dioptre Standard Deviation 7.439	2.50 prism dioptre Standard Deviation 9.899	-7.65 prism dioptre Standard Deviation 4.090	-6.00 prism dioptre Standard Deviation 6.811	-12.95 prism dioptre Standard Deviation 13.150
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	-4.88 prism dioptre Standard Deviation 10.103	-1.75 prism dioptre Standard Deviation 3.889	-6.50 prism dioptre Standard Deviation 5.990	-7.65 prism dioptre Standard Deviation 8.573	-11.60 prism dioptre Standard Deviation 16.244
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	-4.63 prism dioptre Standard Deviation 8.845	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-6.21 prism dioptre Standard Deviation 4.091	-6.00 prism dioptre Standard Deviation 6.933	-10.28 prism dioptre Standard Deviation 11.514
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-7.33 prism dioptre Standard Deviation 11.579	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-3.40 prism dioptre Standard Deviation 2.679	-8.31 prism dioptre Standard Deviation 8.422	-10.28 prism dioptre Standard Deviation 12.171
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-5.17 prism dioptre Standard Deviation 11.751	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-5.63 prism dioptre Standard Deviation 4.191	-6.86 prism dioptre Standard Deviation 9.335	-10.31 prism dioptre Standard Deviation 16.722
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-4.67 prism dioptre Standard Deviation 13.650	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-2.38 prism dioptre Standard Deviation 2.056	-6.29 prism dioptre Standard Deviation 8.401	-9.94 prism dioptre Standard Deviation 12.486
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-3.33 prism dioptre Standard Deviation 13.503	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-4.75 prism dioptre Standard Deviation 4.213	-5.50 prism dioptre Standard Deviation 9.363	-8.38 prism dioptre Standard Deviation 15.784
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-2.83 prism dioptre Standard Deviation 12.332	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.50 prism dioptre Standard Deviation 3.629	-7.00 prism dioptre Standard Deviation 11.206	-10.19 prism dioptre Standard Deviation 14.909
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-1.00 prism dioptre Standard Deviation 14.000	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-2.00 prism dioptre Standard Deviation 7.382	-6.79 prism dioptre Standard Deviation 9.725	-9.25 prism dioptre Standard Deviation 14.378
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-1.33 prism dioptre Standard Deviation 13.796	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.00 prism dioptre Standard Deviation 4.546	-9.21 prism dioptre Standard Deviation 7.521	-9.94 prism dioptre Standard Deviation 10.722

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=2 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=1 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=2 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=6 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=3 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=1 Participants 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.
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	-1.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because there were not enough participants analyzed in this treatment arm at this time point	-7.75 prism dioptre Standard Deviation 1.061	-16.08 prism dioptre Standard Deviation 9.641	-7.83 prism dioptre Standard Deviation 7.006	-9.50 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because there were not enough participants analyzed in this treatment arm at this time point
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	-3.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because there were not enough participants analyzed in this treatment arm at this time point	-6.75 prism dioptre Standard Deviation 5.303	-11.25 prism dioptre Standard Deviation 9.010	-11.83 prism dioptre Standard Deviation 1.756	-6.50 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because there were not enough participants analyzed in this treatment arm at this time point
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 10.960	-3.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because there were not enough participants analyzed in this treatment arm at this time point	2.75 prism dioptre Standard Deviation 11.667	-12.33 prism dioptre Standard Deviation 13.717	-10.00 prism dioptre Standard Deviation 3.122	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point
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	1.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because there were not enough participants analyzed in this treatment arm at this time point	1.25 prism dioptre Standard Deviation 3.889	-10.17 prism dioptre Standard Deviation 7.421	-7.67 prism dioptre Standard Deviation 2.517	-4.50 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because there were not enough participants analyzed in this treatment arm at this time point
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 Standard Deviation NA The standard deviation cannot be calculated because there were not enough participants analyzed in this treatment arm at this time point	-2.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because there were not enough participants analyzed in this treatment arm at this time point	3.25 prism dioptre Standard Deviation 4.596	-6.75 prism dioptre Standard Deviation 8.413	-5.83 prism dioptre Standard Deviation 3.819	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point
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	-2.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because there were not enough participants analyzed in this treatment arm at this time point	0.50 prism dioptre Standard Deviation 7.071	-7.42 prism dioptre Standard Deviation 9.308	-2.00 prism dioptre Standard Deviation 6.083	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point
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 Standard Deviation NA The standard deviation cannot be calculated because there were not enough participants analyzed in this treatment arm at this time point	-2.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because there were not enough participants analyzed in this treatment arm at this time point	0.50 prism dioptre Standard Deviation 0.707	-6.83 prism dioptre Standard Deviation 7.387	-2.33 prism dioptre Standard Deviation 4.752	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point

SECONDARY outcome

Timeframe: Weeks 1 and 4 of the FTP

Population: FAS1 Population

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=3 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=4 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=3 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=10 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=10 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=11 Participants 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.
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	9.25 prism dioptre Standard Deviation 7.182	24.00 prism dioptre Standard Deviation 18.358	32.05 prism dioptre Standard Deviation 9.385	14.20 prism dioptre Standard Deviation 21.953	15.55 prism dioptre Standard Deviation 16.090
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	7.50 prism dioptre Standard Deviation 6.137	12.00 prism dioptre Standard Deviation 1.414	33.20 prism dioptre Standard Deviation 9.855	17.15 prism dioptre Standard Deviation 17.645	18.00 prism dioptre Standard Deviation 18.126

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=3 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=4 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=3 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=10 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=10 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=11 Participants 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.
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	9.25 prism dioptre Standard Deviation 7.182	21.00 prism dioptre Standard Deviation 20.809	22.60 prism dioptre Standard Deviation 14.261	14.20 prism dioptre Standard Deviation 21.953	12.91 prism dioptre Standard Deviation 16.386
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	10.67 prism dioptre Standard Deviation 12.897	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	30.75 prism dioptre Standard Deviation 12.639	24.14 prism dioptre Standard Deviation 10.633	24.69 prism dioptre Standard Deviation 12.587
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	7.50 prism dioptre Standard Deviation 6.137	12.00 prism dioptre Standard Deviation 4.243	21.85 prism dioptre Standard Deviation 11.626	17.40 prism dioptre Standard Deviation 17.980	15.73 prism dioptre Standard Deviation 17.934
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	7.50 prism dioptre Standard Deviation 5.323	17.75 prism dioptre Standard Deviation 1.061	24.85 prism dioptre Standard Deviation 12.985	21.70 prism dioptre Standard Deviation 14.442	20.95 prism dioptre Standard Deviation 18.570
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	10.00 prism dioptre Standard Deviation 6.481	18.25 prism dioptre Standard Deviation 6.010	26.10 prism dioptre Standard Deviation 10.501	24.55 prism dioptre Standard Deviation 10.289	21.50 prism dioptre Standard Deviation 14.193
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 4.950	10.13 prism dioptre Standard Deviation 9.313	14.00 prism dioptre Standard Deviation 0.000	28.50 prism dioptre Standard Deviation 12.684	22.90 prism dioptre Standard Deviation 12.030	22.85 prism dioptre Standard Deviation 17.626
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 4.950	10.38 prism dioptre Standard Deviation 8.138	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	27.36 prism dioptre Standard Deviation 11.775	23.50 prism dioptre Standard Deviation 9.031	23.00 prism dioptre Standard Deviation 13.720
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 NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	8.00 prism dioptre Standard Deviation 10.966	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	30.10 prism dioptre Standard Deviation 12.577	22.38 prism dioptre Standard Deviation 9.837	23.00 prism dioptre Standard Deviation 12.186
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	10.17 prism dioptre Standard Deviation 10.797	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	27.50 prism dioptre Standard Deviation 15.199	23.57 prism dioptre Standard Deviation 11.638	24.31 prism dioptre Standard Deviation 18.225
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	12.00 prism dioptre Standard Deviation 12.530	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	28.38 prism dioptre Standard Deviation 15.617	24.93 prism dioptre Standard Deviation 12.654	26.25 prism dioptre Standard Deviation 16.466
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	12.50 prism dioptre Standard Deviation 10.966	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	31.63 prism dioptre Standard Deviation 14.739	23.43 prism dioptre Standard Deviation 14.243	24.44 prism dioptre Standard Deviation 15.562
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	14.33 prism dioptre Standard Deviation 12.662	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	31.13 prism dioptre Standard Deviation 17.731	23.64 prism dioptre Standard Deviation 12.877	25.38 prism dioptre Standard Deviation 14.665
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	14.00 prism dioptre Standard Deviation 12.490	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	32.13 prism dioptre Standard Deviation 15.644	21.21 prism dioptre Standard Deviation 9.309	24.69 prism dioptre Standard Deviation 11.065

SECONDARY outcome

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

Population: FAS2 population.

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=2 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=1 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=2 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=6 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=3 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=1 Participants 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.
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	12.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	16.25 prism dioptre Standard Deviation 4.596	27.33 prism dioptre Standard Deviation 9.621	28.50 prism dioptre Standard Deviation 14.807	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.
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	13.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	8.00 prism dioptre Standard Deviation 2.828	18.08 prism dioptre Standard Deviation 10.097	23.00 prism dioptre Standard Deviation 15.395	13.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.
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	11.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	9.00 prism dioptre Standard Deviation 1.414	22.92 prism dioptre Standard Deviation 10.646	19.00 prism dioptre Standard Deviation 11.822	16.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.
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	11.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	18.50 prism dioptre Standard Deviation 7.778	21.83 prism dioptre Standard Deviation 12.356	20.83 prism dioptre Standard Deviation 10.867	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.
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	15.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	17.00 prism dioptre Standard Deviation 0.000	24.00 prism dioptre Standard Deviation 9.690	23.17 prism dioptre Standard Deviation 11.514	18.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	12.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	19.00 prism dioptre Standard Deviation 0.707	27.42 prism dioptre Standard Deviation 11.222	25.00 prism dioptre Standard Deviation 11.456	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.
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	12.00 prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	16.25 prism dioptre Standard Deviation 3.182	26.75 prism dioptre Standard Deviation 13.171	28.83 prism dioptre Standard Deviation 15.543	NA prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.

SECONDARY outcome

Timeframe: Baseline and Weeks 1 and 4 of the FTP

Population: FAS1 Population

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.

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=3 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=4 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=3 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=10 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=10 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=11 Participants 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.
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 • Interval 8.491 to -35.98	-35.98 Percent change in prism dioptre Standard Deviation 48.460	68.00 Percent change in prism dioptre Standard Deviation 136.601	-5.33 Percent change in prism dioptre Standard Deviation 9.956	-56.91 Percent change in prism dioptre Standard Deviation 67.224	-61.28 Percent change in prism dioptre Standard Deviation 37.603
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 • Interval 36.745 to	-47.98 Percent change in prism dioptre Standard Deviation 42.069	-22.55 Percent change in prism dioptre Standard Deviation 10.112	-2.32 Percent change in prism dioptre Standard Deviation 7.337	-47.19 Percent change in prism dioptre Standard Deviation 51.238	-52.40 Percent change in prism dioptre Standard Deviation 46.823

SECONDARY outcome

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

Population: FAS1 Population

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

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=3 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=4 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=3 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=10 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=10 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=11 Participants 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.
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	-35.98 Percent change in prism dioptre Standard Deviation 48.460	47.17 Percent change in prism dioptre Standard Deviation 151.828	-37.64 Percent change in prism dioptre Standard Deviation 27.691	-56.91 Percent change in prism dioptre Standard Deviation 67.224	-66.98 Percent change in prism dioptre Standard Deviation 40.186
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	-47.98 Percent change in prism dioptre Standard Deviation 42.069	-18.00 Percent change in prism dioptre Standard Deviation 47.235	-38.96 Percent change in prism dioptre Standard Deviation 20.351	-46.56 Percent change in prism dioptre Standard Deviation 51.832	-57.80 Percent change in prism dioptre Standard Deviation 46.560
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	-48.43 Percent change in prism dioptre Standard Deviation 35.871	15.40 Percent change in prism dioptre Standard Deviation 21.779	-30.50 Percent change in prism dioptre Standard Deviation 23.971	-32.40 Percent change in prism dioptre Standard Deviation 34.610	-41.62 Percent change in prism dioptre Standard Deviation 44.030
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	-31.23 Percent change in prism dioptre Standard Deviation 44.523	24.40 Percent change in prism dioptre Standard Deviation 68.872	-24.69 Percent change in prism dioptre Standard Deviation 14.030	-21.09 Percent change in prism dioptre Standard Deviation 22.844	-38.02 Percent change in prism dioptre Standard Deviation 34.387
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 19.870	-30.13 Percent change in prism dioptre Standard Deviation 62.986	-8.30 Percent change in prism dioptre Standard Deviation 22.627	-22.00 Percent change in prism dioptre Standard Deviation 19.920	-27.16 Percent change in prism dioptre Standard Deviation 28.721	-34.80 Percent change in prism dioptre Standard Deviation 39.312
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 19.870	-28.93 Percent change in prism dioptre Standard Deviation 55.046	NA Percent change in prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-21.60 Percent change in prism dioptre Standard Deviation 17.290	-20.59 Percent change in prism dioptre Standard Deviation 23.190	-31.97 Percent change in prism dioptre Standard Deviation 29.371
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-46.10 Percent change in prism dioptre Standard Deviation 72.788	NA Percent change in prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-13.32 Percent change in prism dioptre Standard Deviation 13.777	-27.75 Percent change in prism dioptre Standard Deviation 28.362	-29.84 Percent change in prism dioptre Standard Deviation 31.502
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 NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point	-30.80 Percent change in prism dioptre Standard Deviation 71.776	NA Percent change in prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-21.75 Percent change in prism dioptre Standard Deviation 18.746	-23.81 Percent change in prism dioptre Standard Deviation 30.638	-31.00 Percent change in prism dioptre Standard Deviation 41.524
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point	-27.77 Percent change in prism dioptre Standard Deviation 85.545	NA Percent change in prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-8.63 Percent change in prism dioptre Standard Deviation 7.602	-21.53 Percent change in prism dioptre Standard Deviation 27.576	-28.08 Percent change in prism dioptre Standard Deviation 28.243
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point	-18.23 Percent change in prism dioptre Standard Deviation 83.395	NA Percent change in prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-19.65 Percent change in prism dioptre Standard Deviation 20.539	-20.21 Percent change in prism dioptre Standard Deviation 29.986	-24.15 Percent change in prism dioptre Standard Deviation 36.602
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point	-13.97 Percent change in prism dioptre Standard Deviation 74.899	NA Percent change in prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-8.20 Percent change in prism dioptre Standard Deviation 15.849	-25.30 Percent change in prism dioptre Standard Deviation 35.381	-29.48 Percent change in prism dioptre Standard Deviation 33.356
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point	-1.43 Percent change in prism dioptre Standard Deviation 86.222	NA Percent change in prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-11.10 Percent change in prism dioptre Standard Deviation 24.612	-24.39 Percent change in prism dioptre Standard Deviation 30.858	-26.38 Percent change in prism dioptre Standard Deviation 32.674
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point	-3.80 Percent change in prism dioptre Standard Deviation 84.778	NA Percent change in prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-6.78 Percent change in prism dioptre Standard Deviation 14.954	-30.91 Percent change in prism dioptre Standard Deviation 25.390	-28.09 Percent change in prism dioptre Standard Deviation 24.167

SECONDARY outcome

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

Population: FAS2 Population

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=2 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=1 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=2 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=6 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=3 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=1 Participants 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.
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	-14.30 Percent change in prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	25.00 Percent change in prism dioptre Standard Deviation 35.355	-20.08 Percent change in prism dioptre Standard Deviation 23.559	-20.70 Percent change in prism dioptre Standard Deviation 12.804	NA Percent change in prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.
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	-14.30 Percent change in prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	9.00 Percent change in prism dioptre Standard Deviation 47.093	-23.57 Percent change in prism dioptre Standard Deviation 27.185	-10.97 Percent change in prism dioptre Standard Deviation 21.594	NA Percent change in prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.
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 Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	-14.30 Percent change in prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	2.70 Percent change in prism dioptre Standard Deviation 3.818	-19.68 Percent change in prism dioptre Standard Deviation 21.456	-12.13 Percent change in prism dioptre Standard Deviation 21.004	NA Percent change in prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.
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	7.10 Percent change in prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	11.35 Percent change in prism dioptre Standard Deviation 27.506	-29.87 Percent change in prism dioptre Standard Deviation 21.927	-27.77 Percent change in prism dioptre Standard Deviation 13.999	-20.00 Percent change in prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.
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	-7.10 Percent change in prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	-49.85 Percent change in prism dioptre Standard Deviation 5.586	-46.75 Percent change in prism dioptre Standard Deviation 26.774	-30.50 Percent change in prism dioptre Standard Deviation 26.754	-42.20 Percent change in prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.
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	-21.40 Percent change in prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	-39.95 Percent change in prism dioptre Standard Deviation 23.829	-33.33 Percent change in prism dioptre Standard Deviation 27.466	-43.13 Percent change in prism dioptre Standard Deviation 21.925	-28.90 Percent change in prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.
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	-21.40 Percent change in prism dioptre Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	27.45 Percent change in prism dioptre Standard Deviation 80.822	-33.95 Percent change in prism dioptre Standard Deviation 32.783	-35.10 Percent change in prism dioptre Standard Deviation 14.224	NA Percent change in prism dioptre Standard Deviation NA No participants in this treatment arm were analyzed at this time point.

SECONDARY outcome

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

Population: FAS1 Population

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.

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=3 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=4 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=3 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=10 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=10 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=11 Participants 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.
Duration of Effect	113.0 Days Interval 28.0 to 231.0	138.0 Days Interval 85.0 to The upper level of this confidence interval was not calculated because the data was censored.	27.0 Days Interval 6.0 to 63.0	113.5 Days Interval 49.0 to 147.0	80.0 Days Interval 25.0 to 190.0	84.0 Days Interval 28.0 to 224.0

SECONDARY outcome

Timeframe: Week 1 and Week 4 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.

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.

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=3 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=4 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=3 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=10 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=10 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=11 Participants 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.
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-1.3 Scores on a scale Standard Deviation 0.96
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-1.0 Scores on a scale Standard Deviation 1.41

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=3 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=4 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=3 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=10 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=10 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=11 Participants 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.
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-1.0 Scores on a scale Standard Deviation 1.73
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-0.3 Scores on a scale Standard Deviation 0.58
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-0.3 Scores on a scale Standard Deviation 0.58
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-0.3 Scores on a scale Standard Deviation 0.58
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-0.7 Scores on a scale Standard Deviation 1.15
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-0.7 Scores on a scale Standard Deviation 1.15
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-0.7 Scores on a scale Standard Deviation 1.15
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-0.3 Scores on a scale Standard Deviation 0.58
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-0.7 Scores on a scale Standard Deviation 1.15
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-0.3 Scores on a scale Standard Deviation 0.58
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-1.0 Scores on a scale Standard Deviation 1.15
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-1.0 Scores on a scale Standard Deviation 1.41
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	-1.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	-0.7 Scores on a scale Standard Deviation 1.15

SECONDARY outcome

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

Population: FAS2 Population

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=3 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=4 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=3 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=10 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=10 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=11 Participants 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.
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	1.0 Scores on a scale Standard Deviation 2.83
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	0.8 Scores on a scale Standard Deviation 1.71

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 n=3 Participants Participants (Par) with a Baseline strabismus angle (BSA) \>=10 prism dioptre (PD) and \<20 PD received no treatment at 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) or 2.5 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.	BSA >=10 PD and <20 PD: GSK1358820 1.25 U n=4 Participants 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.	BSA >=10 PD and <20 PD: GSK1358820 2.5 U n=3 Participants Par with a BSA \>=10 PD and \<20 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.	SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 n=10 Participants Par with a BSA \>=20 PD and \<50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 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 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.	BSA >=20 PD and <50 PD: GSK1358820 2.5 U n=10 Participants Par 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, 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.	BSA >=20 PD and <50 PD: GSK1358820 5.0 U n=11 Participants 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.
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	1.0 Scores on a scale Standard Deviation 1.41
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	1.7 Scores on a scale Standard Deviation 3.06
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	2.3 Scores on a scale Standard Deviation 2.31
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	2.3 Scores on a scale Standard Deviation 2.31
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	2.0 Scores on a scale Standard Deviation 2.65
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	2.3 Scores on a scale Standard Deviation 2.31
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	2.0 Scores on a scale Standard Deviation 2.65
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	2.0 Scores on a scale Standard Deviation 2.65
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	2.0 Scores on a scale Standard Deviation 2.65
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	2.0 Scores on a scale Standard Deviation 2.65
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	2.3 Scores on a scale Standard Deviation 2.31
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	2.3 Scores on a scale Standard Deviation 2.31
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 Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant has been analyzed in this treatment arm at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	NA Scores on a scale Standard Deviation NA No participants in this treatment arm were analyzed at this time point.	0.0 Scores on a scale Standard Deviation NA The standard deviation cannot be calculated because only one participant was analyzed in this treatment arm at this time point.	1.0 Scores on a scale Standard Deviation 2.83

SECONDARY outcome

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

Population: FAS2 Population

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.

Outcome measures

Outcome data not reported

Adverse Events

Non-treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Non-treatment, Then GSK1358820

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

GSK1358820 1.25 U

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

GSK1358820 2.5 U

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

GSK1358820 5.0 U

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Non-treatment n=13 participants at risk Participants (par) with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the First Treatment Period (FTP). Par were re-evaluated at Week 4 and Weeks 12-24. Par who did not meet the injection criteria at any time point remained in the FTP group and were observed up to study Week 52.	Non-treatment, Then GSK1358820 n=13 participants at risk Par with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the 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.	GSK1358820 1.25 U n=4 participants at risk Par with a BSA greater than or equal to 10 PD and less than 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.	GSK1358820 2.5 U n=13 participants at risk Participants with BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 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, 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.	GSK1358820 5.0 U n=11 participants at risk Par with a BSA greater than or equal to 20 PD and less than 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.
Eye disorders Strabismus	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.

Other adverse events

Other adverse events
Measure	Non-treatment n=13 participants at risk Participants (par) with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the First Treatment Period (FTP). Par were re-evaluated at Week 4 and Weeks 12-24. Par who did not meet the injection criteria at any time point remained in the FTP group and were observed up to study Week 52.	Non-treatment, Then GSK1358820 n=13 participants at risk Par with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the 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.	GSK1358820 1.25 U n=4 participants at risk Par with a BSA greater than or equal to 10 PD and less than 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.	GSK1358820 2.5 U n=13 participants at risk Participants with BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 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, 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.	GSK1358820 5.0 U n=11 participants at risk Par with a BSA greater than or equal to 20 PD and less than 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.
Eye disorders Strabismus	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	9.1% 1/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Eye disorders Eyelid ptosis	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	23.1% 3/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	15.4% 2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	18.2% 2/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Eye disorders Conjunctival haemorrhage	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	9.1% 1/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Eye disorders Conjunctival hyperaemia	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	15.4% 2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Eye disorders Diplopia	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	9.1% 1/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Eye disorders Eye movement disorder	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Eye disorders Conjunctival deposit	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Eye disorders Conjunctivitis allergic	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	25.0% 1/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Eye disorders Corneal erosion	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Eye disorders Dry eye	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Eye disorders Ophthalmoplegia	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Eye disorders Punctate keratitis	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Infections and infestations Nasopharyngitis	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	15.4% 2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Infections and infestations Bronchitis	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Infections and infestations Gastroenteritis	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	15.4% 2/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Infections and infestations Helicobacter infection	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Infections and infestations Pharyngitis	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Infections and infestations Sinusitis	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Infections and infestations Urinary tract infection	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Gastrointestinal disorders Dental caries	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Gastrointestinal disorders Vomiting	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	9.1% 1/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
General disorders Therapeutic response increased	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	9.1% 1/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Injury, poisoning and procedural complications Periorbital contusion	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	9.1% 1/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Investigations Liver function test abnormal	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Renal and urinary disorders Calculus urinary	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	9.1% 1/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Skin and subcutaneous tissue disorders Acne	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Ear and labyrinth disorders Vertigo positional	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	7.7% 1/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
Vascular disorders Hypertension	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.	9.1% 1/11 • Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized. SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.

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