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The primary objective of this study is to demonstrate superiority of single treatment of GSK1358820 (hereinafter, referred to as BOTOX®) over placebo in terms of the efficacy of treatment with BOTOX® 50 U in each axilla (100 U in total for each patient) as intradermal injections based on gravimetric assessment (measurement of spontaneous axillary sweat production) for axillary hyperhidrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1358820 | Active Comparator | Onabotulinum toxin type A |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1358820 | Drug | Onabotulinum toxin type A |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First 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. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First 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. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating. |
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Inclusion Criteria:
<At start of the screening phase (Visit 1)>
At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.)
Patients with primary axillary hyperhidrosis whose excessive sweating in each axillae interferes daily life activities and whose Hyperhidrosis Disease Severity Scale (HDSS) score is 3 or 4.
Age of 20 to 75 years at the time of informed consent.
Both genders are eligible to enrol in the study. For men, only those who can practice contraception during the study period are eligible. Women of childbearing potential may be enrolled only if they have negative pregnancy test both in the screening period and just before treatment. Women of childbearing potential must agree to use one or more of the following reliable contraceptive measures throughout the study period:
*: Abstinence, oral contraceptives, progesterone injection, levonorgestrel implant, estrogen ring, transdermal contraceptives, intrauterine device, vasectomized partner, and double-barrier contraception (condom or diaphragm with spermicidal jelly/film).
QTc <450 msec, or QTc <480 msec in patients with bundle branch block. (QTc should be determined on one beat on echocardiogram (ECG) or determined by average on consecutive three beats.)
Willing and able to provide written informed consent. <At start of the treatment phase (Visit 2)>
At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.)
Patients with primary axillary hyperhidrosis whose excessive sweating in each axillae interferes daily life activities and whose HDSS score is 3 or 4.
Asparate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2 x upper limit of normal (ULN), Alkaline phosphatase (ALP) and bilirubin <= 1.5 x ULN at Visit 1 (Free bilirubin >= 1.5 × ULN will not directly lead to study discontinuation if bilirubin fraction test result of direct bilirubin <35% is available.)
Exclusion Criteria:
<At start of the screening phase (Visit 1)>
<At start of the treatment phase (Visit 2)>
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aichi | 480-1195 | Japan | |||
| GSK Investigational Site |
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Treatment Phase (TP) |
|
| |||||||||||||||||||||
| Second TP |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First 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. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating. | 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. | Posted | Number | percentage of participants | Week 4 |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| Drug |
Placebo |
|
| Weeks 1, 8 ,12, 16, 20, and 24 |
| 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 | 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. | Week 0 (Baseline); Weeks 1, 4, 8, 12, 16, 20, and 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 | 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. | Week 0 (Baseline); and Weeks 1, 4, 8, 12, 16, 20, and 24 |
| Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First 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. A responder was defined as a participant whose change from Baseline was equal to or less than -2. | Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| 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 | 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. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| Participant's Global Assessment of Treatment Satisfaction in the First 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. | Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
| Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 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. 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. | 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 |
| Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 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. | 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 |
| Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 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. | 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 |
| Percentage of Responders Assessed by the HDSS in 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. 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. | 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 |
| Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | 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. | 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 |
| Duration of Effect | 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. | Up to Week 40 |
| Kanagawa |
| 220-6208 |
| Japan |
| GSK Investigational Site | Miyagi | 983-0039 | Japan |
| GSK Investigational Site | Saitama | 330-0854 | Japan |
| GSK Investigational Site | Tokyo | 107-0052 | Japan |
| GSK Investigational Site | Tokyo | 113-8519 | Japan |
| GSK Investigational Site | Tokyo | 141-8625 | Japan |
| GSK Investigational Site | Tokyo | 158-0094 | Japan |
| GSK Investigational Site | Tokyo | 158-0097 | Japan |
| GSK Investigational Site | Tokyo | 165-0026 | Japan |
| GSK Investigational Site | Tokyo | 166-0003 | Japan |
| GSK Investigational Site | Tokyo | 174-0071 | Japan |
| GSK Investigational Site | Tokyo | 178-0063 | Japan |
| GSK Investigational Site | Tokyo | 182-0002 | Japan |
| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| OG001 | 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. |
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| Secondary | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First 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. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating. | 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. | Posted | Number | percentage of participants | Weeks 1, 8 ,12, 16, 20, and 24 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | milligrams (mg) | Week 0 (Baseline); Weeks 1, 4, 8, 12, 16, 20, and 24 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Week 0 (Baseline); and Weeks 1, 4, 8, 12, 16, 20, and 24 |
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| Secondary | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First 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. A responder was defined as a participant whose change from Baseline was equal to or less than -2. | 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. | Posted | Number | percentage of participants | Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | Participant's Global Assessment of Treatment Satisfaction in the First 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 |
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| Secondary | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 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. 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. | 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. | Posted | Number | percentage of participants | 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 |
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| Secondary | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 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. | FAS2 (LOCF dataset) | Posted | Mean | Standard Deviation | mg | 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 |
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| Secondary | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 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. | Posted | Mean | Standard Deviation | percent change | 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 |
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| Secondary | Percentage of Responders Assessed by the HDSS in 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. 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. | 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. | Posted | Number | percentage of participants | 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 |
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| Secondary | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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| Secondary | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 |
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|
|
| Secondary | Duration of Effect | 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. | FAS1 | Posted | Median | 95% Confidence Interval | days | Up to Week 40 |
|
|
|
| 1 |
| 144 |
| 23 |
| 144 |
| EG001 | 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. | 1 | 74 | 9 | 74 |
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
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.
| Week 12 |
|
| Week 16 |
|
| Week 20 |
|
| Week 24 |
|
| Week 4 |
|
| Week 8 |
|
| Week 12 |
|
| Week 16 |
|
| Week 20 |
|
| Week 24 |
|
| Week 8 |
|
| Week 12 |
|
| Week 16 |
|
| Week 20 |
|
| Week 24 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=75, 73 |
|
| Week 24, n=76, 72 |
|
| Week 28, n=76, 71 |
|
| Week 32, n=74, 71 |
|
| Week 36, n=75, 70 |
|
| Week 40, n=74, 70 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 13 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Week 8, n=78, 73 |
|
| Week 12, n=76, 73 |
|
| Week 16, n=76, 73 |
|
| Week 20, n=65, 24 |
|
| Week 24, n=56, 15 |
|
| Week 28, n=42, 6 |
|
| Week 32, n=40, 7 |
|
| Week 36, n=41, 7 |
|
| Week 40, n=40, 7 |
|
| Title | Measurements |
|---|---|
|
| Week 12 |
|
| Week 16 |
|
|
| Week 8 |
|
| Week 12 |
|
| Week 16 |
|
|
| Week 12 |
|
| Week 16 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|
|
| Week 12, n=34, 64, 98 |
|
| Week 16, n=34, 62, 96 |
|
| Week 20, n=20, 56, 76 |
|
| Week 24, n=10, 49, 59 |
|