| Primary | Proportion of Composite Responders Who Achieve at Least a 1-point Reduction From Baseline in Glabellar Line Severity Score (GLSS) at Maximum Frown. | Proportion of composite responders who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) based on subject and blinded-evaluator assessment of glabellar line severity at maximum frown on Day 30. | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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| Secondary | Proportion of Responders, at Maximum Frown (Subject) | Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by subject using a static 4-point categorical (subject) scale. | | Posted | | Count of Participants | | Participants | | 120 days | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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| Secondary | Proportion of Responders, at Maximum Frown (Blinded Evaluator) | Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by blinded evaluator using a validated 4-point photographic scale. | | Posted | | Count of Participants | | Participants | | 120 days | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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| Secondary | Proportion of Responders, at Maximum Frown (Treating Investigator) | Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by treating investigator using a validated 4-point photographic scale. | | Posted | | Count of Participants | | Participants | | 120 days | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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| Secondary | Proportion of Combination Responders, at Maximum Frown (Blinded Evaluator and Subject) | Proportion of combination responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator and subject. | | Posted | | Count of Participants | | Participants | | 120 days | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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| Secondary | Proportion of Responders, at Rest (Subject) | Proportion of responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by subject using a static 4-point categorical (subject) scale. | | Posted | | Count of Participants | | Participants | | 120 days | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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| Secondary | Proportion of Responders, at Rest (Blinded Evaluator) | Proportion of responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator using a validated 4-point photographic scale. | | Posted | | Count of Participants | | Participants | | 120 days | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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| Secondary | Proportion of Responders, at Rest (Treating Investigator) | Proportion of combination responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by treating investigator using a validated 4-point photographic scale. | | Posted | | Count of Participants | | Participants | | 120 days | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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| Secondary | Proportion of Combination Responders, at Rest (Blinded Evaluator and Subject) | Proportion of combination responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator and subject. | | Posted | | Count of Participants | | Participants | | 120 days | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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| Secondary | Proportion of Subjects Who Achieved an Onset of Effect on the Appearance of the Subject's Glabellar Lines. | Combination endpoint from both subject and blinded evaluator assessments. Assessments made on days 2, 3, 4, and 7. | | Posted | | Count of Participants | | Participants | | 7 days | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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| Secondary | Subject Satisfaction With the Treatment of Glabellar Lines - I am Satisfied With How I Look. | Proportion of subjects who responded 'agree' or 'strongly agree' regarding change from baseline in subject satisfaction questionnaire on day 120. | | Posted | | Count of Participants | | Participants | | 120 days | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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| Secondary | Investigator Satisfaction With Treatment Outcome - Satisfied With the Study Product Results | Proportion of treating investigators who responded 'agree' or 'strongly agree' to the individual satisfaction questions on Day 30. | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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| Secondary | Subject Psychological Well-being - Mean Change at Day 120 Compared to Baseline | Mean change from baseline on day 120 using the Psychological Well-Being (FACE-Q).Total score for entire questionnaire is transformed to a Rasch score, scale of 0-100. Increase in score = increased well-being. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Day 120 | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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| Secondary | Subject Age Appraisal Using the FACE-Q-Age Appraisal Visual Analog Scale (VAS) - Mean Change at Day 120 Compared to Baseline | Mean change from baseline on day 120 using the FACE-Q Age Appraisal VAS. "0" years represents "current age subjects rated their appearance as older or younger than current age"; "+" years represents "older than current age"; "-" years represents "younger than current age". | | Posted | | Mean | Standard Deviation | years | | Baseline and Day 120 | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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| Secondary | Subject Appraisal of Lines Between the Eyebrows (FACE-Q) - Mean Change at Day 120 Compared to Baseline | Mean change from baseline on day 120 using the Subject Appraisal Lines Between the Eyebrows (FACE-Q).Total score for entire questionnaire is transformed to a Rasch score, scale of 0-100. Increase in score = less bothered by glabellar lines. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Day 120 | | | | ID | Title | Description |
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| OG000 | 1.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 1.5 mL (0.05 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 1.5 mL (0.05 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. | | OG001 | 2.5 mL Reconstitution | Subjects treated with Dysport reconstituted at 2.5 mL (0.08 mL/injection) following the US on-label guidelines, with each subject receiving a single treatment session (50 units [U]) at the Day 1 visit. Dysport reconstituted at 2.5 mL (0.08 mL/injection): Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown. |
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