| Primary | Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. | The Safety Analysis Set included all participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | Enrollment to Day 120 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
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| Primary | Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement From Baseline Based on Both Investigator's Assessment Using C-APPS and Participant's Self-Assessment Using P-APPS, at Maximum Contraction at Day 14 | The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. The Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme. | The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 14 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
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| Primary | Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14 | The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. | The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 14 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
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| Primary | Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self- Assessment Using P-APPS at Maximum Contraction at Day 14 | The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme. | The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 14 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
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| Secondary | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. | The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 14, 30, 60, 90, and 120 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
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| Secondary | Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme. | The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 14, 30, 60, 90, and 120 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
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| Secondary | Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14 | The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied). | The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 14 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
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| Secondary | Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline) at Day 14 | The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered). | The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
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| Secondary | Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14 | The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered). | The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
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| Secondary | Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14 | The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher summary scores (range: 7-35) indicating greater negative psychosocial impact from the appearance of the neck and lower face. For change from baseline in the ANLFQ: Impacts summary score, positive values indicate worsening and negative values indicate improvement in the psychosocial impact. | The intent-to-treat (ITT) population consisted of all randomized participants. Least squares mean, its standard error (SE), and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
| |
| Secondary | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | The C-APPS evaluates platysma prominence severity and is a static measurement encompassing visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. | The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 14, 30, 60, 90, and 120 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
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| Secondary | Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120 | The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme. | The intent-to-treat (ITT) population consisted of all randomized participants. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 14, 30, 60, 90, and 120 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
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| Secondary | Percentage of Participants Who Achieved a Rating of Minimal or Mild According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14 | The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme. | The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
| |
| Secondary | Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14 | The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied). | The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
| |
| Secondary | Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 2 (Jawline) at Day 14 | The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered). | The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
| |
| Secondary | Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14 | The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered). | The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
| |
| Secondary | Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14 | The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher summary scores (range: 7-35) indicating greater negative psychosocial impact from the appearance of the neck and lower face. For change from baseline in the ANLFQ: Impacts summary score, positive values indicate worsening and negative values indicate improvement in the psychosocial impact. | The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Least squares mean, its standard error (SE), and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
| |
| Secondary | Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90 | The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher scores indicating greater negative impact from the appearance of the neck and lower face. | The modified intent-to-treat (mITT) population consisted of all randomized participants with a baseline summary score of ≥ 19 for the ANLFQ: Impacts questionnaire. Least squares mean, its standard error (SE), and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Days 30, 60, and 90 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo was injected into the platysma muscle on Day 1 | | OG001 | BOTOX | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
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