| Primary | Main Period: Percentage of Glabellar Frown Line (GFL) Responders at Day 30 | The Merz aesthetics scales (MAS) are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. GFL-response was defined as a score of 0 (no) or 1 (mild) and at least two-grade improvement from baseline to Day 30 of main period on MAS for GFL at maximum contraction as assessed by both the investigator and the subject. The MAS for GFL ranged as 0 to 4 where 0 is "No glabellar lines", 1 is "Mild glabellar lines", 2 is "Moderate glabellar lines", 3 is "Severe glabellar lines" and 4 is "Very severe glabellar lines". | Target population of main primary estimand included subjects with HFL, GFL and LCL of moderate to severe intensity at maximum contraction as assessed by investigator and subject according to MAS, as randomized in this study: Subset of subjects randomized to UFL (Group U) or to placebo (Group P) groups, grouped by randomized treatment assignment. | Posted | | Number | | percentage of subjects | | Day 30 | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period. | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Mantel Haenszel | | <0.0001 | | | | | | | | | | | | | | Superiority | | |
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| Primary | Main Period: Percentage of Horizontal Forehead Lines (HFL) Responders at Day 30 | The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. HFL-response was defined as a score of 0 (no) or 1 (mild) and at least two-grade improvement from baseline to Day 30 of main period on MAS for HFL at maximum contraction as assessed by both the investigator and the subject. The MAS for HFL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines". | Target population of main primary estimand included subjects with HFL, GFL and LCL of moderate to severe intensity at maximum contraction as assessed by investigator and subject according to MAS, as randomized in this study: Subset of subjects randomized to UFL (Group U) or to placebo (Group P) groups, grouped by randomized treatment assignment. | Posted | | Number | | percentage of subjects | | Day 30 | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period. | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. |
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| Primary | Main Period: Percentage of Lateral Canthal Lines (LCL) Responders at Day 30 | The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. LCL-response was defined as a score of 0 (no) or 1 (mild) and at least two-grade improvement from baseline to Day 30 of main period on MAS for both left and right LCL at maximum contraction as assessed by both the investigator and the subject. The MAS for LCL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines". | Target population of main primary estimand included subjects with HFL, GFL and LCL of moderate to severe intensity at maximum contraction as assessed by investigator and subject according to MAS, as randomized in this study: Subset of subjects randomized to UFL (Group U) or to placebo (Group P) groups, grouped by randomized treatment assignment. | Posted | | Number | | percentage of subjects | | Day 30 | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period. | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. |
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| Secondary | Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for GFL at Maximum Contraction as Assessed by the Investigator at Day 30 | The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for GFL ranged as 0 to 4 where 0 is "No glabellar lines", 1 is "Mild glabellar lines", 2 is "Moderate glabellar lines", 3 is "Severe glabellar lines" and 4 is "Very severe glabellar lines". | Target population of main key secondary estimand included subjects with HFL, GFL and LCL of moderate to severe intensity at maximum contraction as assessed by investigator and subject according to MAS, as randomized in this study: Subset of subjects randomized to UFL (Group U) or to placebo (Group P) groups, grouped by randomized treatment assignment. | Posted | | Number | | percentage of subjects | | Day 30 | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period. | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. |
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| Secondary | Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for HFL at Maximum Contraction as Assessed by the Investigator at Day 30 | The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for HFL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines". | Target population of main key secondary estimand included subjects with HFL, GFL and LCL of moderate to severe intensity at maximum contraction as assessed by investigator and subject according to MAS, as randomized in this study: Subset of subjects randomized to UFL (Group U) or to placebo (Group P) groups, grouped by randomized treatment assignment. | Posted | | Number | | percentage of subjects | | Day 30 | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period. | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. |
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| Secondary | Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Investigator at Day 30 | The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for LCL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines". | Target population of main key secondary estimand included subjects with HFL, GFL and LCL of moderate to severe intensity at maximum contraction as assessed by investigator and subject according to MAS, as randomized in this study: Subset of subjects randomized to UFL (Group U) or to placebo (Group P) groups, grouped by randomized treatment assignment. | Posted | | Number | | percentage of subjects | | Day 30 | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period. | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. |
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| Secondary | Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for GFL at Maximum Contraction as Assessed by the Subject at Day 30 | The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for GFL ranged as 0 to 4 where 0 is "No glabellar lines", 1 is "Mild glabellar lines", 2 is "Moderate glabellar lines", 3 is "Severe glabellar lines" and 4 is "Very severe glabellar lines". | Target population of main key secondary estimand included subjects with HFL, GFL and LCL of moderate to severe intensity at maximum contraction as assessed by investigator and subject according to MAS, as randomized in this study: Subset of subjects randomized to UFL (Group U) or to placebo (Group P) groups, grouped by randomized treatment assignment. | Posted | | Number | | percentage of subjects | | Day 30 | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period. | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. |
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| Secondary | Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for HFL at Maximum Contraction as Assessed by the Subject at Day 30 | The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for HFL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines". | Target population of main key secondary estimand included subjects with HFL, GFL and LCL of moderate to severe intensity at maximum contraction as assessed by investigator and subject according to MAS, as randomized in this study: Subset of subjects randomized to UFL (Group U) or to placebo (Group P) groups, grouped by randomized treatment assignment. | Posted | | Number | | percentage of subjects | | Day 30 | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period. | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. |
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| Secondary | Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Subject at Day 30 | The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for LCL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines". | Target population of main key secondary estimand included subjects with HFL, GFL and LCL of moderate to severe intensity at maximum contraction as assessed by investigator and subject according to MAS, as randomized in this study: Subset of subjects randomized to UFL (Group U) or to placebo (Group P) groups, grouped by randomized treatment assignment. | Posted | | Number | | percentage of subjects | | Day 30 | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period. | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. |
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| Secondary | Main Period: Global Aesthetic Improvement Scale (GAIS) at Day 30 as Assessed by the Subjects | The GAIS is a 7-point Likert scale capturing the global aesthetic improvement ranging from +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the subject. GAIS as assessed by the subject at Day 30 was analyzed using an analysis of covariance (ANCOVA) model. | Target population of main key secondary estimand included subjects with HFL, GFL and LCL of moderate to severe intensity at maximum contraction as assessed by investigator and subject according to MAS, as randomized in this study: Subset of subjects randomized to UFL (Group U) or to placebo (Group P) groups, grouped by randomized treatment assignment. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Day 30 | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period. | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. |
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| Secondary | Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 on MAS for GFL at Maximum Contraction as Assessed by the Investigator | The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for GFL ranged as 0 to 4 where 0 is "No glabellar lines", 1 is "Mild glabellar lines", 2 is "Moderate glabellar lines", 3 is "Severe glabellar lines" and 4 is "Very severe glabellar lines". | FAS. Here "overall number of subjects analyzed" were subjects who had non-missing data for this outcome measure. | Posted | | Number | | percentage of subjects | | Day 30 | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period. | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. | | OG002 | Main Period: NT 201 and Placebo (Group G and H) | Subjects received a total of 40 U of NT 201: 20 U of NT 201 injection both in the GFL and HFL area, and placebo injection in the LCL area on Day 1 of main period. |
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| Secondary | Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 on MAS for HFL at Maximum Contraction as Assessed by the Investigator | The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for HFL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines". | FAS. Here "overall number of subjects analyzed" were subjects who had non-missing data for this outcome measure. | Posted | | Number | | percentage of subjects | | Day 30 | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period. | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. | | OG002 | Main Period: NT 201 and Placebo (Group G and H) | Subjects received a total of 40 U of NT 201: 20 U of NT 201 injection both in the GFL and HFL area, and placebo injection in the LCL area on Day 1 of main period. |
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| Secondary | Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Investigator | The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for LCL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines". | FAS. Here "overall number of subjects analyzed" were subjects who had non-missing data for this outcome measure. | Posted | | Number | | percentage of subjects | | Day 30 | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period. | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. | | OG002 | Main Period: NT 201 and Placebo (Group G and H) | Subjects received a total of 40 U of NT 201: 20 U of NT 201 injection both in the GFL and HFL area, and placebo injection in the LCL area on Day 1 of main period. |
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| Secondary | Main Period: Global Aesthetic Improvement Scale (GAIS) at Day 30 as Assessed by the Investigator | The GAIS is a 7-point Likert scale capturing the global aesthetic improvement ranging from +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the investigator. GAIS as assessed by the investigator at Day 30 was analyzed using an ANCOVA model. | FAS. Here "overall number of subjects analyzed" were subjects who had non-missing data for this outcome measure. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Day 30 | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period. | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. | | OG002 | Main Period: NT 201 and Placebo (Group G and H) | Subjects received a total of 40 U of NT 201: 20 U of NT 201 injection both in the GFL and HFL area, and placebo injection in the LCL area on Day 1 of main period. |
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| Secondary | Main Period: Number of Subjects With Related Treatment-Emergent Adverse Events (TEAEs) | TEAEs during the Main Period are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment and before date and time of first administration of study treatment in the OLEX period or the final study visit, if subject was not treated in the OLEX period. An AE is considered to be related if a causal relationship between study treatment and the AE is at least reasonably possible. | The Safety Evaluation Set (SES) included all subjects treated. | Posted | | Count of Participants | | Participants | No | Up to 22 Weeks | | | | ID | Title | Description |
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| OG000 | Main Period: Placebo (Group P) | Subjects received placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period | | OG001 | Main Period: NT 201 (Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period. | | OG002 | Main Period: NT 201 and Placebo (Group G and H) | Subjects received a total of 40 U of NT 201: 20 U of NT 201 injection both in the GFL and HFL area, and placebo injection in the LCL area on Day 1 of main period. |
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| Secondary | OLEX Period: Number of Subjects With Related TEAEs | TEAEs of the OLEX period are defined as AEs with onset or worsening on or after date and time of first dose of study treatment in the OLEX period up to and including the final study visit. An AE is considered to be related if a causal relationship between study treatment and the AE is at least reasonably possible. | | Posted | | Count of Participants | | Participants | No | Up to 39 Weeks | | | | ID | Title | Description |
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| OG000 | OLEX: NT 201 (Main Period: Group P) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of (Visit 8) and Visit 13 of OLEX period. | | OG001 | OLEX: NT 201 (Main Period: Group U) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period. | | OG002 | OLEX: NT 201 (Main Period: Group G and H) | Subjects received a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of (Visit 8) and Visit 13 of OLEX period. |
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