Trial Outcomes & Findings for GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary Hyperhidrosis (NCT NCT01128738)

NCT ID: NCT01128738

Last Updated: 2015-06-08

Results Overview

A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 152 participants
• Primary outcome timeframe: Week 4
• Results posted on: 2015-06-08

Participant Flow

This study consisted of a Screening Phase (1- to 2-week period), the First Treatment Phase (16- to 40-week period after first treatment), and the open-label Second Treatment Phase (16- to 24-week period after reinjection). All participants were observed until Week 40 after the first treatment irrespective of whether they received reinjection or not

Participant milestones

Measure	BTX 50 U in First and Second TPs Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
First Treatment Phase (TP) STARTED	78	74
First Treatment Phase (TP) COMPLETED	74	73
First Treatment Phase (TP) NOT COMPLETED	4	1
Second TP STARTED	34	66
Second TP COMPLETED	34	63
Second TP NOT COMPLETED	0	3

Reasons for withdrawal

Measure	BTX 50 U in First and Second TPs Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
First Treatment Phase (TP) Lost to Follow-up	1	0
First Treatment Phase (TP) Withdrawal by Subject	3	1
Second TP Lost to Follow-up	0	1
Second TP Withdrawal by Subject	0	2

Baseline Characteristics

GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary Hyperhidrosis

Baseline characteristics by cohort

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=152 Participants Total of all reporting groups
Age, Continuous	36.2 Years STANDARD_DEVIATION 10.05 • n=93 Participants	34.7 Years STANDARD_DEVIATION 11.69 • n=4 Participants	35.5 Years STANDARD_DEVIATION 10.87 • n=27 Participants
Sex: Female, Male Female	61 Participants n=93 Participants	55 Participants n=4 Participants	116 Participants n=27 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	19 Participants n=4 Participants	36 Participants n=27 Participants
Race/Ethnicity, Customized Asian-Japanese Heritage	78 participants n=93 Participants	74 participants n=4 Participants	152 participants n=27 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Full Analysis Set for the First Treatment Phase (FAS1): all participants who received the first treatment of investigational product (IP) and had at least 1 post-Baseline efficacy assessment. The analysis was performed using the Last Observation Carried Forward (LOCF) dataset; missing data were imputed by carrying forward the last available data.

A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First Treatment Phase	96.2 percentage of participants	45.9 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 1, 8 ,12, 16, 20, and 24

Population: FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.

A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 1	93.6 percentage of participants	52.7 percentage of participants	—
Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 8	94.9 percentage of participants	48.6 percentage of participants	—
Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 12	89.7 percentage of participants	62.2 percentage of participants	—
Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 16	87.2 percentage of participants	32.4 percentage of participants	—
Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 20	74.4 percentage of participants	20.3 percentage of participants	—
Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 24	56.4 percentage of participants	9.5 percentage of participants	—

SECONDARY outcome

Timeframe: Week 0 (Baseline); Weeks 1, 4, 8, 12, 16, 20, and 24

Population: FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.

A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 1	17.58 milligrams (mg) Standard Deviation 21.725	81.30 milligrams (mg) Standard Deviation 117.296	—
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 24	44.27 milligrams (mg) Standard Deviation 71.909	135.36 milligrams (mg) Standard Deviation 159.123	—
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 0 (Baseline)	125.16 milligrams (mg) Standard Deviation 85.366	137.45 milligrams (mg) Standard Deviation 128.215	—
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 4	18.90 milligrams (mg) Standard Deviation 36.500	82.92 milligrams (mg) Standard Deviation 98.940	—
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 8	15.47 milligrams (mg) Standard Deviation 24.471	80.43 milligrams (mg) Standard Deviation 121.172	—
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 12	17.99 milligrams (mg) Standard Deviation 28.380	68.31 milligrams (mg) Standard Deviation 67.493	—
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 16	18.60 milligrams (mg) Standard Deviation 26.827	115.44 milligrams (mg) Standard Deviation 157.710	—
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 20	24.90 milligrams (mg) Standard Deviation 31.793	127.30 milligrams (mg) Standard Deviation 161.965	—

SECONDARY outcome

Timeframe: Week 0 (Baseline); and Weeks 1, 4, 8, 12, 16, 20, and 24

Population: FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.

A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline was calculated as follows: (mean weight at each visit minus mean weight at Baseline) * 100/mean weight at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 1	-82.4 percent change Standard Deviation 24.40	-44.5 percent change Standard Deviation 53.32	—
Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 4	-87.0 percent change Standard Deviation 16.00	-34.3 percent change Standard Deviation 55.77	—
Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 8	-84.8 percent change Standard Deviation 25.07	-37.3 percent change Standard Deviation 51.64	—
Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 12	-81.0 percent change Standard Deviation 37.10	-33.6 percent change Standard Deviation 80.24	—
Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 16	-78.8 percent change Standard Deviation 40.39	-5.2 percent change Standard Deviation 109.55	—
Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 20	-71.2 percent change Standard Deviation 43.99	1.9 percent change Standard Deviation 108.77	—
Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase Week 24	-55.6 percent change Standard Deviation 69.41	8.6 percent change Standard Deviation 105.13	—

SECONDARY outcome

Timeframe: Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants remaining in the study at the time of the visit, particularly regardless of reinjection after Week 16, was used as the denominator. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline was equal to or less than -2.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase Week 4, n=78, 73	61.5 percentage of participants	13.7 percentage of participants	—
Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase Week 8, n=78, 73	66.7 percentage of participants	12.3 percentage of participants	—
Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase Week 12, n=76, 73	57.9 percentage of participants	13.7 percentage of participants	—
Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase Week 24, n=76, 72	38.2 percentage of participants	6.9 percentage of participants	—
Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase Week 28, n=76, 71	36.8 percentage of participants	4.2 percentage of participants	—
Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase Week 32, n=74, 71	32.4 percentage of participants	4.2 percentage of participants	—
Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase Week 36, n=75, 70	30.7 percentage of participants	4.3 percentage of participants	—
Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase Week 40, n=74, 70	27.0 percentage of participants	4.3 percentage of participants	—
Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase Week 1, n=78, 74	32.1 percentage of participants	8.1 percentage of participants	—
Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase Week 16, n=76, 73	57.9 percentage of participants	9.6 percentage of participants	—
Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase Week 20, n=75, 73	48.0 percentage of participants	9.6 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-1.1 scores on a scale Standard Deviation 0.84	-0.5 scores on a scale Standard Deviation 0.71	—
Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-1.6 scores on a scale Standard Deviation 0.80	-0.5 scores on a scale Standard Deviation 0.84	—
Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-1.7 scores on a scale Standard Deviation 0.75	-0.5 scores on a scale Standard Deviation 0.77	—
Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-1.6 scores on a scale Standard Deviation 0.77	-0.7 scores on a scale Standard Deviation 0.80	—
Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-1.6 scores on a scale Standard Deviation 0.75	-0.6 scores on a scale Standard Deviation 0.71	—
Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-1.6 scores on a scale Standard Deviation 0.72	-1.0 scores on a scale Standard Deviation 0.78	—
Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-1.6 scores on a scale Standard Deviation 0.78	-1.1 scores on a scale Standard Deviation 0.88	—
Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-1.7 scores on a scale Standard Deviation 0.55	-1.5 scores on a scale Standard Deviation 0.55	—
Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-1.6 scores on a scale Standard Deviation 0.63	-1.6 scores on a scale Standard Deviation 0.79	—
Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-1.6 scores on a scale Standard Deviation 0.63	-1.6 scores on a scale Standard Deviation 0.79	—
Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-1.5 scores on a scale Standard Deviation 0.64	-1.6 scores on a scale Standard Deviation 0.79	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-6.9 scores on a scale Standard Deviation 4.77	-3.1 scores on a scale Standard Deviation 4.53	—
Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-6.9 scores on a scale Standard Deviation 4.82	-4.1 scores on a scale Standard Deviation 5.70	—
Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-5.4 scores on a scale Standard Deviation 4.61	-1.8 scores on a scale Standard Deviation 3.49	—
Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-6.6 scores on a scale Standard Deviation 4.82	-1.7 scores on a scale Standard Deviation 3.66	—
Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-6.9 scores on a scale Standard Deviation 4.72	-2.0 scores on a scale Standard Deviation 3.89	—
Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-6.9 scores on a scale Standard Deviation 4.41	-2.5 scores on a scale Standard Deviation 4.26	—
Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-7.3 scores on a scale Standard Deviation 4.66	-5.0 scores on a scale Standard Deviation 4.73	—
Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-7.1 scores on a scale Standard Deviation 4.69	-3.9 scores on a scale Standard Deviation 6.47	—
Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-6.9 scores on a scale Standard Deviation 4.48	-2.5 scores on a scale Standard Deviation 4.25	—
Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-6.7 scores on a scale Standard Deviation 4.34	-3.1 scores on a scale Standard Deviation 4.37	—
Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-6.5 scores on a scale Standard Deviation 4.75	-4.4 scores on a scale Standard Deviation 5.19	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-1.3 scores on a scale Standard Deviation 0.99	-0.3 scores on a scale Standard Deviation 1.04	—
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-1.5 scores on a scale Standard Deviation 1.13	-1.2 scores on a scale Standard Deviation 0.98	—
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-1.3 scores on a scale Standard Deviation 1.11	-0.7 scores on a scale Standard Deviation 1.50	—
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=8, 74	-0.9 scores on a scale Standard Deviation 0.97	-0.2 scores on a scale Standard Deviation 0.95	—
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-1.2 scores on a scale Standard Deviation 1.01	-0.2 scores on a scale Standard Deviation 0.90	—
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-1.3 scores on a scale Standard Deviation 1.16	-0.3 scores on a scale Standard Deviation 0.87	—
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-1.3 scores on a scale Standard Deviation 1.04	-0.4 scores on a scale Standard Deviation 0.96	—
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-1.3 scores on a scale Standard Deviation 1.19	-0.6 scores on a scale Standard Deviation 1.06	—
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-1.2 scores on a scale Standard Deviation 1.07	-0.5 scores on a scale Standard Deviation 1.06	—
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-1.4 scores on a scale Standard Deviation 1.08	-0.7 scores on a scale Standard Deviation 1.50	—
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-1.3 scores on a scale Standard Deviation 1.06	-0.9 scores on a scale Standard Deviation 1.21	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-1.8 scores on a scale Standard Deviation 1.76	-0.6 scores on a scale Standard Deviation 1.40	—
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-2.2 scores on a scale Standard Deviation 1.67	-0.5 scores on a scale Standard Deviation 1.33	—
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-2.4 scores on a scale Standard Deviation 1.74	-0.6 scores on a scale Standard Deviation 1.44	—
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-2.3 scores on a scale Standard Deviation 1.56	-1.1 scores on a scale Standard Deviation 1.35	—
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-2.4 scores on a scale Standard Deviation 1.68	-1.2 scores on a scale Standard Deviation 1.57	—
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-2.5 scores on a scale Standard Deviation 1.69	-1.5 scores on a scale Standard Deviation 1.52	—
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-2.4 scores on a scale Standard Deviation 1.66	-1.4 scores on a scale Standard Deviation 1.62	—
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-2.4 scores on a scale Standard Deviation 1.77	-1.3 scores on a scale Standard Deviation 1.38	—
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-2.1 scores on a scale Standard Deviation 1.76	-1.6 scores on a scale Standard Deviation 1.62	—
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-2.4 scores on a scale Standard Deviation 1.63	-0.9 scores on a scale Standard Deviation 1.45	—
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-2.4 scores on a scale Standard Deviation 1.63	-1.0 scores on a scale Standard Deviation 1.38	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-1.7 scores on a scale Standard Deviation 1.50	-0.7 scores on a scale Standard Deviation 1.38	—
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-1.7 scores on a scale Standard Deviation 1.51	-0.8 scores on a scale Standard Deviation 1.45	—
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-1.4 scores on a scale Standard Deviation 1.62	-0.5 scores on a scale Standard Deviation 1.37	—
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-1.6 scores on a scale Standard Deviation 1.60	-0.6 scores on a scale Standard Deviation 1.33	—
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-1.7 scores on a scale Standard Deviation 1.52	-0.7 scores on a scale Standard Deviation 1.45	—
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-1.7 scores on a scale Standard Deviation 1.56	-1.0 scores on a scale Standard Deviation 1.53	—
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-1.9 scores on a scale Standard Deviation 1.67	-0.8 scores on a scale Standard Deviation 1.52	—
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-1.8 scores on a scale Standard Deviation 1.59	-1.3 scores on a scale Standard Deviation 1.63	—
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-1.8 scores on a scale Standard Deviation 1.72	-1.1 scores on a scale Standard Deviation 2.19	—
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-1.7 scores on a scale Standard Deviation 1.76	-1.1 scores on a scale Standard Deviation 2.19	—
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-1.7 scores on a scale Standard Deviation 1.71	-1.0 scores on a scale Standard Deviation 1.91	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-0.7 scores on a scale Standard Deviation 0.65	-0.6 scores on a scale Standard Deviation 0.53	—
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-0.7 scores on a scale Standard Deviation 0.75	-0.1 scores on a scale Standard Deviation 0.76	—
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-0.7 scores on a scale Standard Deviation 0.79	-0.1 scores on a scale Standard Deviation 0.69	—
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-0.5 scores on a scale Standard Deviation 0.64	-0.2 scores on a scale Standard Deviation 0.57	—
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-0.7 scores on a scale Standard Deviation 0.79	-0.2 scores on a scale Standard Deviation 0.74	—
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-0.6 scores on a scale Standard Deviation 0.78	-0.1 scores on a scale Standard Deviation 0.71	—
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-0.7 scores on a scale Standard Deviation 0.73	-0.3 scores on a scale Standard Deviation 0.82	—
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-0.7 scores on a scale Standard Deviation 0.78	-0.2 scores on a scale Standard Deviation 0.86	—
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-0.8 scores on a scale Standard Deviation 0.73	-0.5 scores on a scale Standard Deviation 0.55	—
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-0.8 scores on a scale Standard Deviation 0.66	-0.1 scores on a scale Standard Deviation 1.46	—
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-0.8 scores on a scale Standard Deviation 0.82	-0.4 scores on a scale Standard Deviation 0.79	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-0.4 scores on a scale Standard Deviation 0.80	-0.1 scores on a scale Standard Deviation 0.70	—
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-0.4 scores on a scale Standard Deviation 0.81	-0.3 scores on a scale Standard Deviation 0.76	—
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-0.4 scores on a scale Standard Deviation 0.81	-0.3 scores on a scale Standard Deviation 0.76	—
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-0.4 scores on a scale Standard Deviation 0.83	-0.1 scores on a scale Standard Deviation 0.64	—
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-0.4 scores on a scale Standard Deviation 0.83	-0.2 scores on a scale Standard Deviation 0.68	—
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 13	-0.4 scores on a scale Standard Deviation 0.81	-0.2 scores on a scale Standard Deviation 0.80	—
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-0.4 scores on a scale Standard Deviation 0.88	-0.2 scores on a scale Standard Deviation 0.84	—
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-0.4 scores on a scale Standard Deviation 0.81	-0.1 scores on a scale Standard Deviation 0.74	—
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-0.4 scores on a scale Standard Deviation 0.85	-0.1 scores on a scale Standard Deviation 0.61	—
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-0.4 scores on a scale Standard Deviation 0.79	-0.3 scores on a scale Standard Deviation 0.82	—
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-0.4 scores on a scale Standard Deviation 0.80	-0.3 scores on a scale Standard Deviation 0.76	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-0.3 scores on a scale Standard Deviation 0.65	-0.1 scores on a scale Standard Deviation 0.48	—
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-0.4 scores on a scale Standard Deviation 0.69	-0.1 scores on a scale Standard Deviation 0.71	—
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-0.4 scores on a scale Standard Deviation 0.69	-0.2 scores on a scale Standard Deviation 0.62	—
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-0.4 scores on a scale Standard Deviation 0.66	-0.1 scores on a scale Standard Deviation 0.63	—
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-0.4 scores on a scale Standard Deviation 0.63	-0.1 scores on a scale Standard Deviation 0.61	—
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-0.3 scores on a scale Standard Deviation 0.56	-0.1 scores on a scale Standard Deviation 0.38	—
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-0.3 scores on a scale Standard Deviation 0.64	-0.1 scores on a scale Standard Deviation 0.38	—
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-0.3 scores on a scale Standard Deviation 0.69	-0.2 scores on a scale Standard Deviation 0.56	—
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-0.3 scores on a scale Standard Deviation 0.64	-0.2 scores on a scale Standard Deviation 0.41	—
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-0.4 scores on a scale Standard Deviation 0.62	-0.1 scores on a scale Standard Deviation 0.65	—
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-0.3 scores on a scale Standard Deviation 0.57	-0.3 scores on a scale Standard Deviation 0.49	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The scores for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	0.0 scores on a scale Standard Deviation 0.42	0.1 scores on a scale Standard Deviation 0.26	—
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-0.1 scores on a scale Standard Deviation 0.22	0.0 scores on a scale Standard Deviation 0.00	—
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-0.1 scores on a scale Standard Deviation 0.33	0.0 scores on a scale Standard Deviation 0.33	—
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-0.1 scores on a scale Standard Deviation 0.42	-0.1 scores on a scale Standard Deviation 0.40	—
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-0.1 scores on a scale Standard Deviation 0.40	0.0 scores on a scale Standard Deviation 0.39	—
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-0.1 scores on a scale Standard Deviation 0.51	0.2 scores on a scale Standard Deviation 0.38	—
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	0.0 scores on a scale Standard Deviation 0.31	0.0 scores on a scale Standard Deviation 0.00	—
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	0.0 scores on a scale Standard Deviation 0.27	0.0 scores on a scale Standard Deviation 0.00	—
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-0.1 scores on a scale Standard Deviation 0.32	0.0 scores on a scale Standard Deviation 0.00	—
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	0.0 scores on a scale Standard Deviation 0.47	0.0 scores on a scale Standard Deviation 0.39	—
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-0.1 scores on a scale Standard Deviation 0.48	0.0 scores on a scale Standard Deviation 0.46	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-1.2 scores on a scale Standard Deviation 1.02	-0.6 scores on a scale Standard Deviation 0.92	—
Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-0.9 scores on a scale Standard Deviation 0.94	-0.2 scores on a scale Standard Deviation 0.92	—
Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-1.1 scores on a scale Standard Deviation 1.00	-0.2 scores on a scale Standard Deviation 0.87	—
Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-1.2 scores on a scale Standard Deviation 1.05	-0.3 scores on a scale Standard Deviation 0.85	—
Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-1.4 scores on a scale Standard Deviation 1.04	-1.2 scores on a scale Standard Deviation 0.98	—
Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-1.2 scores on a scale Standard Deviation 1.02	-0.3 scores on a scale Standard Deviation 0.91	—
Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-1.2 scores on a scale Standard Deviation 0.96	-0.3 scores on a scale Standard Deviation 0.94	—
Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-1.3 scores on a scale Standard Deviation 1.06	-0.7 scores on a scale Standard Deviation 0.98	—
Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-1.4 scores on a scale Standard Deviation 1.00	-0.7 scores on a scale Standard Deviation 1.50	—
Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-1.3 scores on a scale Standard Deviation 1.01	-0.7 scores on a scale Standard Deviation 1.50	—
Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-1.2 scores on a scale Standard Deviation 0.97	-0.9 scores on a scale Standard Deviation 1.21	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-0.8 scores on a scale Standard Deviation 1.03	-0.2 scores on a scale Standard Deviation 0.75	—
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-0.8 scores on a scale Standard Deviation 0.98	-0.4 scores on a scale Standard Deviation 0.89	—
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-0.8 scores on a scale Standard Deviation 0.97	-0.4 scores on a scale Standard Deviation 0.86	—
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-0.6 scores on a scale Standard Deviation 1.01	-0.2 scores on a scale Standard Deviation 0.77	—
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-0.8 scores on a scale Standard Deviation 1.02	-0.2 scores on a scale Standard Deviation 0.76	—
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-0.8 scores on a scale Standard Deviation 0.96	-0.3 scores on a scale Standard Deviation 0.75	—
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-0.8 scores on a scale Standard Deviation 1.05	-0.4 scores on a scale Standard Deviation 0.91	—
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-0.9 scores on a scale Standard Deviation 0.92	-0.5 scores on a scale Standard Deviation 0.84	—
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-0.9 scores on a scale Standard Deviation 0.97	-0.6 scores on a scale Standard Deviation 0.79	—
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-0.9 scores on a scale Standard Deviation 0.97	-0.6 scores on a scale Standard Deviation 0.79	—
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-0.8 scores on a scale Standard Deviation 1.04	-0.6 scores on a scale Standard Deviation 0.79	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-1.2 scores on a scale Standard Deviation 1.03	-0.5 scores on a scale Standard Deviation 0.88	—
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-1.5 scores on a scale Standard Deviation 0.92	-0.3 scores on a scale Standard Deviation 0.90	—
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-1.3 scores on a scale Standard Deviation 0.94	-1.0 scores on a scale Standard Deviation 1.15	—
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-1.6 scores on a scale Standard Deviation 1.00	-0.4 scores on a scale Standard Deviation 1.01	—
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-1.6 scores on a scale Standard Deviation 1.02	-0.5 scores on a scale Standard Deviation 0.90	—
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-1.6 scores on a scale Standard Deviation 0.97	-0.6 scores on a scale Standard Deviation 0.91	—
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-1.5 scores on a scale Standard Deviation 0.87	-0.8 scores on a scale Standard Deviation 0.78	—
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-1.5 scores on a scale Standard Deviation 0.91	-0.8 scores on a scale Standard Deviation 1.08	—
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-1.6 scores on a scale Standard Deviation 1.06	-1.0 scores on a scale Standard Deviation 0.89	—
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-1.5 scores on a scale Standard Deviation 0.96	-0.9 scores on a scale Standard Deviation 1.21	—
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-1.5 scores on a scale Standard Deviation 1.00	-0.7 scores on a scale Standard Deviation 1.11	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-0.8 scores on a scale Standard Deviation 0.94	-0.2 scores on a scale Standard Deviation 0.80	—
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-0.9 scores on a scale Standard Deviation 0.92	-0.3 scores on a scale Standard Deviation 0.82	—
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-1.1 scores on a scale Standard Deviation 0.97	-0.1 scores on a scale Standard Deviation 0.70	—
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-1.1 scores on a scale Standard Deviation 0.98	-0.5 scores on a scale Standard Deviation 0.84	—
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-1.1 scores on a scale Standard Deviation 1.02	-0.4 scores on a scale Standard Deviation 1.51	—
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-1.0 scores on a scale Standard Deviation 1.02	-0.4 scores on a scale Standard Deviation 0.98	—
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-1.1 scores on a scale Standard Deviation 0.99	-0.4 scores on a scale Standard Deviation 0.98	—
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-1.0 scores on a scale Standard Deviation 0.94	-0.4 scores on a scale Standard Deviation 0.84	—
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-1.0 scores on a scale Standard Deviation 0.92	-0.3 scores on a scale Standard Deviation 0.86	—
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-1.0 scores on a scale Standard Deviation 0.93	-0.3 scores on a scale Standard Deviation 0.75	—
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-1.0 scores on a scale Standard Deviation 0.95	-0.4 scores on a scale Standard Deviation 0.86	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-0.6 scores on a scale Standard Deviation 0.94	-0.3 scores on a scale Standard Deviation 0.85	—
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-0.7 scores on a scale Standard Deviation 1.00	-0.3 scores on a scale Standard Deviation 0.85	—
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-0.7 scores on a scale Standard Deviation 0.91	-0.4 scores on a scale Standard Deviation 0.86	—
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-0.7 scores on a scale Standard Deviation 0.94	-0.4 scores on a scale Standard Deviation 0.91	—
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-0.7 scores on a scale Standard Deviation 0.94	-0.4 scores on a scale Standard Deviation 0.90	—
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-0.7 scores on a scale Standard Deviation 0.94	-0.7 scores on a scale Standard Deviation 1.16	—
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-0.7 scores on a scale Standard Deviation 0.94	-0.7 scores on a scale Standard Deviation 1.10	—
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-0.7 scores on a scale Standard Deviation 0.87	-0.8 scores on a scale Standard Deviation 0.98	—
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-0.7 scores on a scale Standard Deviation 0.92	-0.7 scores on a scale Standard Deviation 0.95	—
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-0.7 scores on a scale Standard Deviation 0.99	-0.7 scores on a scale Standard Deviation 1.38	—
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-0.7 scores on a scale Standard Deviation 0.94	-0.6 scores on a scale Standard Deviation 1.13	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1 The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-0.7 scores on a scale Standard Deviation 0.79	-0.2 scores on a scale Standard Deviation 0.74	—
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-0.6 scores on a scale Standard Deviation 0.78	-0.1 scores on a scale Standard Deviation 0.71	—
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-0.7 scores on a scale Standard Deviation 0.75	-0.1 scores on a scale Standard Deviation 0.76	—
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-0.7 scores on a scale Standard Deviation 0.79	-0.1 scores on a scale Standard Deviation 0.69	—
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-0.5 scores on a scale Standard Deviation 0.64	-0.2 scores on a scale Standard Deviation 0.57	—
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-0.7 scores on a scale Standard Deviation 0.73	-0.3 scores on a scale Standard Deviation 0.82	—
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-0.7 scores on a scale Standard Deviation 0.78	-0.2 scores on a scale Standard Deviation 0.86	—
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-0.8 scores on a scale Standard Deviation 0.73	-0.5 scores on a scale Standard Deviation 0.55	—
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-0.8 scores on a scale Standard Deviation 0.66	-0.1 scores on a scale Standard Deviation 1.46	—
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-0.8 scores on a scale Standard Deviation 0.82	-0.4 scores on a scale Standard Deviation 0.79	—
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-0.7 scores on a scale Standard Deviation 0.65	-0.6 scores on a scale Standard Deviation 0.53	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-0.3 scores on a scale Standard Deviation 0.58	-0.1 scores on a scale Standard Deviation 0.42	—
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-0.3 scores on a scale Standard Deviation 0.57	-0.1 scores on a scale Standard Deviation 0.45	—
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-0.3 scores on a scale Standard Deviation 0.54	-0.1 scores on a scale Standard Deviation 0.51	—
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-0.3 scores on a scale Standard Deviation 0.54	-0.1 scores on a scale Standard Deviation 0.55	—
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-0.3 scores on a scale Standard Deviation 0.54	-0.1 scores on a scale Standard Deviation 0.60	—
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-0.3 scores on a scale Standard Deviation 0.52	-0.1 scores on a scale Standard Deviation 0.41	—
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-0.3 scores on a scale Standard Deviation 0.53	-0.1 scores on a scale Standard Deviation 0.46	—
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-0.3 scores on a scale Standard Deviation 0.50	-0.2 scores on a scale Standard Deviation 0.41	—
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-0.3 scores on a scale Standard Deviation 0.51	-0.1 scores on a scale Standard Deviation 0.38	—
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-0.2 scores on a scale Standard Deviation 0.49	-0.1 scores on a scale Standard Deviation 0.38	—
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-0.3 scores on a scale Standard Deviation 0.51	-0.1 scores on a scale Standard Deviation 0.38	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase Week 1, n=78, 74	-0.2 scores on a scale Standard Deviation 0.40	0.0 scores on a scale Standard Deviation 0.31	—
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase Week 4, n=78, 73	-0.1 scores on a scale Standard Deviation 0.39	-0.1 scores on a scale Standard Deviation 0.33	—
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase Week 8, n=78, 73	-0.1 scores on a scale Standard Deviation 0.42	-0.1 scores on a scale Standard Deviation 0.33	—
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase Week 12, n=76, 73	-0.1 scores on a scale Standard Deviation 0.39	-0.1 scores on a scale Standard Deviation 0.40	—
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase Week 16, n=76, 73	-0.1 scores on a scale Standard Deviation 0.47	0.0 scores on a scale Standard Deviation 0.37	—
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase Week 20, n=65, 24	-0.1 scores on a scale Standard Deviation 0.39	0.0 scores on a scale Standard Deviation 0.36	—
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase Week 24, n=56, 15	-0.1 scores on a scale Standard Deviation 0.41	0.0 scores on a scale Standard Deviation 0.38	—
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase Week 28, n=42, 6	-0.1 scores on a scale Standard Deviation 0.40	-0.2 scores on a scale Standard Deviation 0.41	—
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase Week 32, n=40, 7	-0.1 scores on a scale Standard Deviation 0.40	-0.1 scores on a scale Standard Deviation 0.38	—
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase Week 36, n=41, 7	-0.1 scores on a scale Standard Deviation 0.40	-0.1 scores on a scale Standard Deviation 0.38	—
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase Week 40, n=40, 7	-0.1 scores on a scale Standard Deviation 0.40	-0.1 scores on a scale Standard Deviation 0.38	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 20, n=65, 24	-0.4 scores on a scale Standard Deviation 0.63	-0.1 scores on a scale Standard Deviation 0.61	—
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 24, n=56, 15	-0.3 scores on a scale Standard Deviation 0.69	-0.2 scores on a scale Standard Deviation 0.56	—
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 16, n=76, 73	-0.4 scores on a scale Standard Deviation 0.66	-0.1 scores on a scale Standard Deviation 0.63	—
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 1, n=78, 74	-0.3 scores on a scale Standard Deviation 0.65	-0.1 scores on a scale Standard Deviation 0.48	—
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 4, n=78, 73	-0.4 scores on a scale Standard Deviation 0.69	-0.1 scores on a scale Standard Deviation 0.71	—
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 12, n=76, 73	-0.4 scores on a scale Standard Deviation 0.62	-0.1 scores on a scale Standard Deviation 0.65	—
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 28, n=42, 6	-0.3 scores on a scale Standard Deviation 0.64	-0.2 scores on a scale Standard Deviation 0.41	—
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 32, n=40, 7	-0.3 scores on a scale Standard Deviation 0.56	-0.1 scores on a scale Standard Deviation 0.38	—
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 36, n=41, 7	-0.3 scores on a scale Standard Deviation 0.57	-0.3 scores on a scale Standard Deviation 0.49	—
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 40, n=40, 7	-0.3 scores on a scale Standard Deviation 0.64	-0.1 scores on a scale Standard Deviation 0.38	—
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase Week 8, n=78, 73	-0.4 scores on a scale Standard Deviation 0.69	-0.2 scores on a scale Standard Deviation 0.62	—

SECONDARY outcome

Timeframe: Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.

The participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase Week 1, n=78, 74	1.8 scores on a scale Standard Deviation 1.28	0.6 scores on a scale Standard Deviation 0.95	—
Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase Week 4, n=78, 73	2.6 scores on a scale Standard Deviation 10.7	0.5 scores on a scale Standard Deviation 1.05	—
Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase Week 20, n=65, 24	2.6 scores on a scale Standard Deviation 1.14	0.5 scores on a scale Standard Deviation 1.06	—
Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase Week 24, n=56, 15	2.5 scores on a scale Standard Deviation 1.21	0.9 scores on a scale Standard Deviation 1.22	—
Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase Week 28, n=42, 6	2.9 scores on a scale Standard Deviation 0.88	1.0 scores on a scale Standard Deviation 1.26	—
Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase Week 32, n=40, 7	2.6 scores on a scale Standard Deviation 1.37	1.3 scores on a scale Standard Deviation 1.38	—
Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase Week 36, n=41, 7	2.5 scores on a scale Standard Deviation 1.31	1.0 scores on a scale Standard Deviation 1.63	—
Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase Week 40, n=40, 7	2.4 scores on a scale Standard Deviation 1.35	1.1 scores on a scale Standard Deviation 1.46	—
Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase Week 8, n=78, 73	2.7 scores on a scale Standard Deviation 1.16	0.3 scores on a scale Standard Deviation 0.96	—
Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase Week 12, n=76, 73	2.6 scores on a scale Standard Deviation 1.33	0.4 scores on a scale Standard Deviation 0.86	—
Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase Week 16, n=76, 73	2.6 scores on a scale Standard Deviation 1.23	0.4 scores on a scale Standard Deviation 0.83	—

SECONDARY outcome

Timeframe: Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase

Population: FAS for the Second Treatment Phase (FAS2) (LOCF dataset): all participants who were included in the FAS1, received the second treatment of IP, and had at least one efficacy assessment after the second treatment. One participant who started the Second Treatment Phase was not included in the FAS2 because they had no efficacy assessment in this phase.

A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline (Week 0 in the Second Treatment Phase) in mean weight of axillary sweating.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase Week 8	94.1 percentage of participants	96.9 percentage of participants	96.0 percentage of participants
Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase Week 12	97.1 percentage of participants	96.9 percentage of participants	97.0 percentage of participants
Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase Week 16	91.2 percentage of participants	95.4 percentage of participants	93.9 percentage of participants
Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase Week 4	97.1 percentage of participants	92.3 percentage of participants	93.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0); Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase

Population: FAS2 (LOCF dataset)

A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase Baseline (Week 0)	84.50 mg Standard Deviation 92.872	145.39 mg Standard Deviation 163.635	124.48 mg Standard Deviation 145.725
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase Week 4	6.69 mg Standard Deviation 7.513	17.25 mg Standard Deviation 35.386	13.62 mg Standard Deviation 29.363
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase Week 8	11.37 mg Standard Deviation 26.561	17.82 mg Standard Deviation 36.049	15.61 mg Standard Deviation 33.102
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase Week 12	15.22 mg Standard Deviation 27.057	14.20 mg Standard Deviation 20.411	14.55 mg Standard Deviation 22.778
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase Week 16	12.87 mg Standard Deviation 15.458	14.49 mg Standard Deviation 21.217	13.94 mg Standard Deviation 19.366

SECONDARY outcome

Timeframe: Baseline (Week 0); and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase

A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline in the Second Treatment phase was calculated as follows: (mean weight at each visit minus mean weight at Baseline in the Second Treatment Phase) * 100/mean weight at Baseline in the Second Treatment Phase.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase Week 16	-77.6 percent change Standard Deviation 32.23	-84.5 percent change Standard Deviation 24.87	-82.1 percent change Standard Deviation 27.65
Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase Week 4	-89.6 percent change Standard Deviation 15.20	-84.6 percent change Standard Deviation 31.18	-86.3 percent change Standard Deviation 26.80
Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase Week 8	-86.2 percent change Standard Deviation 16.76	-84.4 percent change Standard Deviation 33.85	-85.0 percent change Standard Deviation 29.04
Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase Week 12	-82.6 percent change Standard Deviation 18.43	-87.6 percent change Standard Deviation 21.14	-85.9 percent change Standard Deviation 20.30

SECONDARY outcome

Timeframe: Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline (Week 0 in the Second Treatment Phase) was equal to or less than -2.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Percentage of Responders Assessed by the HDSS in the Second Treatment Phase Week 12, n=34, 64, 98	8.8 percentage of participants	48.4 percentage of participants	34.7 percentage of participants
Percentage of Responders Assessed by the HDSS in the Second Treatment Phase Week 16, n=34, 62, 96	2.9 percentage of participants	43.5 percentage of participants	29.2 percentage of participants
Percentage of Responders Assessed by the HDSS in the Second Treatment Phase Week 20, n=20, 56, 76	0 percentage of participants	37.5 percentage of participants	27.6 percentage of participants
Percentage of Responders Assessed by the HDSS in the Second Treatment Phase Week 24, n=10, 49, 59	0 percentage of participants	36.7 percentage of participants	30.5 percentage of participants
Percentage of Responders Assessed by the HDSS in the Second Treatment Phase Week 4, n=34, 65, 99	11.8 percentage of participants	47.7 percentage of participants	35.4 percentage of participants
Percentage of Responders Assessed by the HDSS in the Second Treatment Phase Week 8, n=34, 65, 99	14.7 percentage of participants	43.1 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.9 scores on a scale Standard Deviation 0.61	-1.5 scores on a scale Standard Deviation 0.79	-1.3 scores on a scale Standard Deviation 0.79
Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.9 scores on a scale Standard Deviation 0.65	-1.4 scores on a scale Standard Deviation 0.70	-1.2 scores on a scale Standard Deviation 0.72
Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-0.8 scores on a scale Standard Deviation 0.64	-1.4 scores on a scale Standard Deviation 0.75	-1.2 scores on a scale Standard Deviation 0.77
Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.6 scores on a scale Standard Deviation 0.54	-1.3 scores on a scale Standard Deviation 0.80	-1.1 scores on a scale Standard Deviation 0.78
Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.6 scores on a scale Standard Deviation 0.51	-1.2 scores on a scale Standard Deviation 0.79	-1.0 scores on a scale Standard Deviation 0.77
Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	-0.3 scores on a scale Standard Deviation 0.67	-1.1 scores on a scale Standard Deviation 0.84	-0.9 scores on a scale Standard Deviation 0.86

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-2.6 scores on a scale Standard Deviation 2.65	-4.0 scores on a scale Standard Deviation 4.21	-3.6 scores on a scale Standard Deviation 3.79
Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-2.4 scores on a scale Standard Deviation 3.18	-4.0 scores on a scale Standard Deviation 4.28	-3.4 scores on a scale Standard Deviation 4.00
Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-2.0 scores on a scale Standard Deviation 2.72	-3.9 scores on a scale Standard Deviation 4.04	-3.2 scores on a scale Standard Deviation 3.74
Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-1.9 scores on a scale Standard Deviation 2.48	-3.7 scores on a scale Standard Deviation 4.46	-3.0 scores on a scale Standard Deviation 3.96
Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-1.3 scores on a scale Standard Deviation 1.41	-3.3 scores on a scale Standard Deviation 4.03	-2.8 scores on a scale Standard Deviation 3.63
Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	-0.7 scores on a scale Standard Deviation 3.20	-3.3 scores on a scale Standard Deviation 4.55	-2.8 scores on a scale Standard Deviation 4.43

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.5 scores on a scale Standard Deviation 0.90	-0.8 scores on a scale Standard Deviation 0.86	-0.7 scores on a scale Standard Deviation 0.88
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.6 scores on a scale Standard Deviation 1.04	-0.8 scores on a scale Standard Deviation 0.89	-0.8 scores on a scale Standard Deviation 0.95
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-0.5 scores on a scale Standard Deviation 0.99	-0.8 scores on a scale Standard Deviation 0.84	-0.7 scores on a scale Standard Deviation 0.91
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.4 scores on a scale Standard Deviation 0.89	-0.7 scores on a scale Standard Deviation 0.93	-0.6 scores on a scale Standard Deviation 0.92
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.3 scores on a scale Standard Deviation 0.66	-0.8 scores on a scale Standard Deviation 0.84	-0.6 scores on a scale Standard Deviation 0.81
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	-0.1 scores on a scale Standard Deviation 1.10	-0.8 scores on a scale Standard Deviation 0.85	-0.7 scores on a scale Standard Deviation 0.92

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-1.1 scores on a scale Standard Deviation 1.07	-1.4 scores on a scale Standard Deviation 1.34	-1.3 scores on a scale Standard Deviation 1.26
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.9 scores on a scale Standard Deviation 1.08	-1.3 scores on a scale Standard Deviation 1.36	-1.2 scores on a scale Standard Deviation 1.28
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-0.8 scores on a scale Standard Deviation 1.06	-1.3 scores on a scale Standard Deviation 1.20	-1.2 scores on a scale Standard Deviation 1.17
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.6 scores on a scale Standard Deviation 1.07	-1.2 scores on a scale Standard Deviation 1.39	-1.0 scores on a scale Standard Deviation 1.31
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.4 scores on a scale Standard Deviation 0.82	-1.0 scores on a scale Standard Deviation 1.33	-0.9 scores on a scale Standard Deviation 1.25
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	-0.6 scores on a scale Standard Deviation 1.07	-1.1 scores on a scale Standard Deviation 1.48	-1.0 scores on a scale Standard Deviation 1.42

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.6 scores on a scale Standard Deviation 0.82	-0.7 scores on a scale Standard Deviation 0.97	-0.6 scores on a scale Standard Deviation 0.92
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.4 scores on a scale Standard Deviation 0.96	-0.7 scores on a scale Standard Deviation 1.02	-0.6 scores on a scale Standard Deviation 1.01
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-0.4 scores on a scale Standard Deviation 0.82	-0.7 scores on a scale Standard Deviation 1.03	-0.6 scores on a scale Standard Deviation 0.96
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.5 scores on a scale Standard Deviation 0.83	-0.6 scores on a scale Standard Deviation 1.01	-0.6 scores on a scale Standard Deviation 0.95
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.3 scores on a scale Standard Deviation 0.47	-0.6 scores on a scale Standard Deviation 0.89	-0.5 scores on a scale Standard Deviation 0.81
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	-0.2 scores on a scale Standard Deviation 0.63	-0.5 scores on a scale Standard Deviation 1.02	-0.5 scores on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.3 scores on a scale Standard Deviation 0.51	-0.6 scores on a scale Standard Deviation 0.83	-0.5 scores on a scale Standard Deviation 0.75
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.2 scores on a scale Standard Deviation 0.65	-0.5 scores on a scale Standard Deviation 0.85	-0.4 scores on a scale Standard Deviation 0.80
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-0.1 scores on a scale Standard Deviation 0.56	-0.5 scores on a scale Standard Deviation 0.93	-0.4 scores on a scale Standard Deviation 0.83
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.2 scores on a scale Standard Deviation 0.43	-0.5 scores on a scale Standard Deviation 0.84	-0.4 scores on a scale Standard Deviation 0.74
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.2 scores on a scale Standard Deviation 0.37	-0.4 scores on a scale Standard Deviation 0.78	-0.4 scores on a scale Standard Deviation 0.71
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	-0.1 scores on a scale Standard Deviation 0.57	-0.4 scores on a scale Standard Deviation 0.91	-0.4 scores on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.1 scores on a scale Standard Deviation 0.29	-0.3 scores on a scale Standard Deviation 0.77	-0.2 scores on a scale Standard Deviation 0.65
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	0.0 scores on a scale Standard Deviation 0.30	-0.3 scores on a scale Standard Deviation 0.81	-0.2 scores on a scale Standard Deviation 0.69
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-0.1 scores on a scale Standard Deviation 0.29	-0.3 scores on a scale Standard Deviation 0.78	-0.2 scores on a scale Standard Deviation 0.66
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	0.0 scores on a scale Standard Deviation 0.30	-0.3 scores on a scale Standard Deviation 0.89	-0.2 scores on a scale Standard Deviation 0.75
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	0.0 scores on a scale Standard Deviation 0.30	-0.3 scores on a scale Standard Deviation 0.73	-0.2 scores on a scale Standard Deviation 0.63
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	0.2 scores on a scale Standard Deviation 0.63	-0.3 scores on a scale Standard Deviation 0.87	-0.2 scores on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.1 scores on a scale Standard Deviation 0.50	-0.3 scores on a scale Standard Deviation 0.59	-0.2 scores on a scale Standard Deviation 0.56
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.1 scores on a scale Standard Deviation 0.36	-0.3 scores on a scale Standard Deviation 0.62	-0.2 scores on a scale Standard Deviation 0.55
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	0.1 scores on a scale Standard Deviation 0.32	-0.2 scores on a scale Standard Deviation 0.73	-0.1 scores on a scale Standard Deviation 0.68
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	0.0 scores on a scale Standard Deviation 0.30	-0.3 scores on a scale Standard Deviation 0.60	-0.2 scores on a scale Standard Deviation 0.52
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.1 scores on a scale Standard Deviation 0.29	-0.2 scores on a scale Standard Deviation 0.73	-0.2 scores on a scale Standard Deviation 0.62
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.1 scores on a scale Standard Deviation 0.31	-0.2 scores on a scale Standard Deviation 0.69	-0.2 scores on a scale Standard Deviation 0.61

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.1 scores on a scale Standard Deviation 0.55	-0.1 scores on a scale Standard Deviation 0.30	-0.1 scores on a scale Standard Deviation 0.40
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.1 scores on a scale Standard Deviation 0.56	-0.1 scores on a scale Standard Deviation 0.35	-0.1 scores on a scale Standard Deviation 0.43
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-0.1 scores on a scale Standard Deviation 0.56	0.0 scores on a scale Standard Deviation 0.38	-0.1 scores on a scale Standard Deviation 0.45
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.1 scores on a scale Standard Deviation 0.50	0.0 scores on a scale Standard Deviation 0.40	-0.1 scores on a scale Standard Deviation 0.44
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.1 scores on a scale Standard Deviation 0.51	-0.1 scores on a scale Standard Deviation 0.32	-0.1 scores on a scale Standard Deviation 0.38
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	0.1 scores on a scale Standard Deviation 0.57	-0.1 scores on a scale Standard Deviation 0.31	-0.1 scores on a scale Standard Deviation 0.37

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.4 scores on a scale Standard Deviation 0.66	-0.8 scores on a scale Standard Deviation 0.79	-0.6 scores on a scale Standard Deviation 0.76
Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.5 scores on a scale Standard Deviation 0.71	-0.8 scores on a scale Standard Deviation 0.81	-0.7 scores on a scale Standard Deviation 0.78
Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-0.3 scores on a scale Standard Deviation 0.84	-0.7 scores on a scale Standard Deviation 0.76	-0.6 scores on a scale Standard Deviation 0.81
Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	-0.2 scores on a scale Standard Deviation 0.63	-0.7 scores on a scale Standard Deviation 0.85	-0.6 scores on a scale Standard Deviation 0.83
Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.3 scores on a scale Standard Deviation 0.67	-0.7 scores on a scale Standard Deviation 0.83	-0.5 scores on a scale Standard Deviation 0.79
Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.3 scores on a scale Standard Deviation 0.44	-0.7 scores on a scale Standard Deviation 0.81	-0.6 scores on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.3 scores on a scale Standard Deviation 0.47	-0.4 scores on a scale Standard Deviation 0.60	-0.4 scores on a scale Standard Deviation 0.56
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.3 scores on a scale Standard Deviation 0.57	-0.3 scores on a scale Standard Deviation 0.59	-0.3 scores on a scale Standard Deviation 0.58
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-0.3 scores on a scale Standard Deviation 0.51	-0.3 scores on a scale Standard Deviation 0.49	-0.3 scores on a scale Standard Deviation 0.50
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.3 scores on a scale Standard Deviation 0.51	-0.3 scores on a scale Standard Deviation 0.57	-0.3 scores on a scale Standard Deviation 0.55
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.2 scores on a scale Standard Deviation 0.41	-0.3 scores on a scale Standard Deviation 0.65	-0.3 scores on a scale Standard Deviation 0.60
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	-0.4 scores on a scale Standard Deviation 0.52	-0.3 scores on a scale Standard Deviation 0.60	-0.3 scores on a scale Standard Deviation 0.59

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.7 scores on a scale Standard Deviation 0.71	-1.0 scores on a scale Standard Deviation 0.93	-0.9 scores on a scale Standard Deviation 0.87
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.6 scores on a scale Standard Deviation 0.69	-1.0 scores on a scale Standard Deviation 0.93	-0.8 scores on a scale Standard Deviation 0.86
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.2 scores on a scale Standard Deviation 0.52	-0.8 scores on a scale Standard Deviation 0.94	-0.6 scores on a scale Standard Deviation 0.88
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	-0.2 scores on a scale Standard Deviation 0.63	-0.8 scores on a scale Standard Deviation 1.08	-0.7 scores on a scale Standard Deviation 1.04
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-0.6 scores on a scale Standard Deviation 0.66	-1.0 scores on a scale Standard Deviation 0.89	-0.9 scores on a scale Standard Deviation 0.85
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.4 scores on a scale Standard Deviation 0.70	-0.9 scores on a scale Standard Deviation 1.03	-0.7 scores on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.3 scores on a scale Standard Deviation 0.59	-0.4 scores on a scale Standard Deviation 0.66	-0.4 scores on a scale Standard Deviation 0.63
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.2 scores on a scale Standard Deviation 0.70	-0.4 scores on a scale Standard Deviation 0.71	-0.4 scores on a scale Standard Deviation 0.71
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-0.3 scores on a scale Standard Deviation 0.62	-0.4 scores on a scale Standard Deviation 0.68	-0.3 scores on a scale Standard Deviation 0.66
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.2 scores on a scale Standard Deviation 0.37	-0.3 scores on a scale Standard Deviation 0.67	-0.3 scores on a scale Standard Deviation 0.61
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	0.0 scores on a scale Standard Deviation 0.00	-0.3 scores on a scale Standard Deviation 0.75	-0.3 scores on a scale Standard Deviation 0.69
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.3 scores on a scale Standard Deviation 0.57	-0.4 scores on a scale Standard Deviation 0.69	-0.3 scores on a scale Standard Deviation 0.65

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.3 scores on a scale Standard Deviation 0.45	-0.3 scores on a scale Standard Deviation 0.54	-0.3 scores on a scale Standard Deviation 0.51
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.2 scores on a scale Standard Deviation 0.52	-0.3 scores on a scale Standard Deviation 0.56	-0.3 scores on a scale Standard Deviation 0.55
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-0.2 scores on a scale Standard Deviation 0.46	-0.3 scores on a scale Standard Deviation 0.60	-0.2 scores on a scale Standard Deviation 0.55
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.2 scores on a scale Standard Deviation 0.48	-0.3 scores on a scale Standard Deviation 0.57	-0.2 scores on a scale Standard Deviation 0.54
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.2 scores on a scale Standard Deviation 0.37	-0.3 scores on a scale Standard Deviation 0.53	-0.3 scores on a scale Standard Deviation 0.49
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	-0.2 scores on a scale Standard Deviation 0.63	-0.2 scores on a scale Standard Deviation 0.54	-0.2 scores on a scale Standard Deviation 0.55

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.3 scores on a scale Standard Deviation 0.51	-0.6 scores on a scale Standard Deviation 0.83	-0.5 scores on a scale Standard Deviation 0.75
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.2 scores on a scale Standard Deviation 0.65	-0.5 scores on a scale Standard Deviation 0.85	-0.4 scores on a scale Standard Deviation 0.80
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-0.1 scores on a scale Standard Deviation 0.56	-0.5 scores on a scale Standard Deviation 0.93	-0.4 scores on a scale Standard Deviation 0.83
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.2 scores on a scale Standard Deviation 0.43	-0.5 scores on a scale Standard Deviation 0.84	-0.4 scores on a scale Standard Deviation 0.74
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.2 scores on a scale Standard Deviation 0.37	-0.4 scores on a scale Standard Deviation 0.78	-0.4 scores on a scale Standard Deviation 0.71
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	-0.1 scores on a scale Standard Deviation 0.57	-0.4 scores on a scale Standard Deviation 0.91	-0.4 scores on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	0.0 scores on a scale Standard Deviation 0.00	-0.2 scores on a scale Standard Deviation 0.49	-0.1 scores on a scale Standard Deviation 0.40
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	0.0 scores on a scale Standard Deviation 0.17	-0.2 scores on a scale Standard Deviation 0.51	-0.1 scores on a scale Standard Deviation 0.43
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	0.0 scores on a scale Standard Deviation 0.17	-0.2 scores on a scale Standard Deviation 0.41	-0.1 scores on a scale Standard Deviation 0.45
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	0.0 scores on a scale Standard Deviation 0.17	-0.2 scores on a scale Standard Deviation 0.52	-0.1 scores on a scale Standard Deviation 0.44
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	0.1 scores on a scale Standard Deviation 0.22	-0.1 scores on a scale Standard Deviation 0.41	-0.1 scores on a scale Standard Deviation 0.38
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	0.2 scores on a scale Standard Deviation 0.63	-0.1 scores on a scale Standard Deviation 0.58	-0.1 scores on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.1 scores on a scale Standard Deviation 0.29	-0.1 scores on a scale Standard Deviation 0.43	-0.1 scores on a scale Standard Deviation 0.39
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.1 scores on a scale Standard Deviation 0.24	-0.2 scores on a scale Standard Deviation 0.44	-0.1 scores on a scale Standard Deviation 0.39
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	-0.1 scores on a scale Standard Deviation 0.24	-0.2 scores on a scale Standard Deviation 0.49	-0.1 scores on a scale Standard Deviation 0.42
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.1 scores on a scale Standard Deviation 0.24	-0.2 scores on a scale Standard Deviation 0.50	-0.1 scores on a scale Standard Deviation 0.43
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.1 scores on a scale Standard Deviation 0.22	-0.2 scores on a scale Standard Deviation 0.46	-0.1 scores on a scale Standard Deviation 0.41
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	0.0 scores on a scale Standard Deviation 0.00	-0.1 scores on a scale Standard Deviation 0.46	-0.1 scores on a scale Standard Deviation 0.42

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 4, n=34, 65, 99	-0.1 scores on a scale Standard Deviation 0.50	-0.3 scores on a scale Standard Deviation 0.59	-0.2 scores on a scale Standard Deviation 0.56
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 8, n=34, 65, 99	-0.1 scores on a scale Standard Deviation 0.36	-0.3 scores on a scale Standard Deviation 0.62	-0.2 scores on a scale Standard Deviation 0.55
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 12, n=34, 64, 98	0.0 scores on a scale Standard Deviation 0.30	-0.3 scores on a scale Standard Deviation 0.60	-0.2 scores on a scale Standard Deviation 0.52
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 24, n=10, 49, 59	0.1 scores on a scale Standard Deviation 0.32	-0.2 scores on a scale Standard Deviation 0.73	-0.1 scores on a scale Standard Deviation 0.68
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 16, n=34, 62, 96	-0.1 scores on a scale Standard Deviation 0.29	-0.2 scores on a scale Standard Deviation 0.73	-0.2 scores on a scale Standard Deviation 0.62
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase Week 20, n=20, 56, 76	-0.1 scores on a scale Standard Deviation 0.31	-0.2 scores on a scale Standard Deviation 0.69	-0.2 scores on a scale Standard Deviation 0.61

SECONDARY outcome

Timeframe: Weeks 4 (Study Week 20 to Week 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase

Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.

Participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=34 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=65 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total n=99 Participants Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase Week 12, n=34, 64, 98	2.8 scores on a scale Standard Deviation 1.14	2.7 scores on a scale Standard Deviation 1.27	2.7 scores on a scale Standard Deviation 1.22
Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase Week 20, n=20, 56, 76	2.3 scores on a scale Standard Deviation 1.29	2.3 scores on a scale Standard Deviation 1.46	2.3 scores on a scale Standard Deviation 1.41
Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase Week 4, n=34, 65, 99	3.2 scores on a scale Standard Deviation 0.88	2.8 scores on a scale Standard Deviation 1.10	2.9 scores on a scale Standard Deviation 1.04
Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase Week 8, n=34, 65, 99	3.0 scores on a scale Standard Deviation 1.14	2.8 scores on a scale Standard Deviation 1.09	2.9 scores on a scale Standard Deviation 1.11
Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase Week 16, n=34, 62, 96	2.6 scores on a scale Standard Deviation 1.35	2.6 scores on a scale Standard Deviation 1.36	2.6 scores on a scale Standard Deviation 1.35
Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase Week 24, n=10, 49, 59	1.7 scores on a scale Standard Deviation 1.34	2.1 scores on a scale Standard Deviation 1.52	2.0 scores on a scale Standard Deviation 1.49

SECONDARY outcome

Timeframe: Up to Week 40

Population: FAS1

Duration of effect is defined as the number of days between the date of first treatment and the date of the first recording of >50% production in gravimetric assessment compared to Baseline.

Outcome measures

Measure	BTX 50 U in First and Second TPs n=78 Participants Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 Participants Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Total Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
Duration of Effect	273.0 days Interval 171.0 to The upper limit of the 95% CI for the median cannot be estimated because the follow-up duration is limited.	35.0 days Interval 28.0 to 56.0	—

Adverse Events

BTX 50 U in First and Second TPs

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo in First TP; BTX 50 U in Second TP

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	BTX 50 U in First and Second TPs n=144 participants at risk Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 participants at risk Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Gastrointestinal disorders Colitis	0.00% 0/144 The number of participants at risk in the BTX arm includes the participants who received at least one BTX treatment in either the First or Second Treatment Periods. The number of participants at risk in the placebo arm includes the participants who received at least one dose of placebo in the First Treatment Period.	1.4% 1/74 The number of participants at risk in the BTX arm includes the participants who received at least one BTX treatment in either the First or Second Treatment Periods. The number of participants at risk in the placebo arm includes the participants who received at least one dose of placebo in the First Treatment Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	0.69% 1/144 The number of participants at risk in the BTX arm includes the participants who received at least one BTX treatment in either the First or Second Treatment Periods. The number of participants at risk in the placebo arm includes the participants who received at least one dose of placebo in the First Treatment Period.	0.00% 0/74 The number of participants at risk in the BTX arm includes the participants who received at least one BTX treatment in either the First or Second Treatment Periods. The number of participants at risk in the placebo arm includes the participants who received at least one dose of placebo in the First Treatment Period.

Other adverse events

Measure	BTX 50 U in First and Second TPs n=144 participants at risk Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.	Placebo in First TP; BTX 50 U in Second TP n=74 participants at risk Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
Infections and infestations Nasopharyngitis	16.0% 23/144 The number of participants at risk in the BTX arm includes the participants who received at least one BTX treatment in either the First or Second Treatment Periods. The number of participants at risk in the placebo arm includes the participants who received at least one dose of placebo in the First Treatment Period.	12.2% 9/74 The number of participants at risk in the BTX arm includes the participants who received at least one BTX treatment in either the First or Second Treatment Periods. The number of participants at risk in the placebo arm includes the participants who received at least one dose of placebo in the First Treatment Period.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER