Trial Outcomes & Findings for MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines (NCT NCT03732833)

NCT ID: NCT03732833

Last Updated: 2023-07-17

Results Overview

The outcome measured is the percentage of participants who had a ≥2-grade improvement from baseline LCL severity at maximum smile according to investigator and participant FWS ratings at Day 30. Both the INVESTIGATOR AND PARTICIPANT evaluate the LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 425 participants
• Primary outcome timeframe: Day 30
• Results posted on: 2023-07-17

Participant Flow

Overall, 602 participants were screened, 424 participants were analyzed in ITT set and 425 participants were analyzed in Safety set.

Participant milestones

Measure	Placebo Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + MT10109L 20U MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Overall Study STARTED	86	171	167
Overall Study COMPLETED	68	138	150
Overall Study NOT COMPLETED	18	33	17

Reasons for withdrawal

Measure	Placebo Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + MT10109L 20U MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Overall Study Adverse Event	0	3	1
Overall Study Withdrawal by Subject	11	13	8
Overall Study Lost to Follow-up	3	5	4
Overall Study Pregnancy	0	2	0
Overall Study Physician Decision	2	3	1
Overall Study Covid-19 related and other reasons	2	7	3

Baseline Characteristics

MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines

Baseline characteristics by cohort

Measure	Placebo n=86 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=171 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=167 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	Total n=424 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants	156 Participants n=7 Participants	157 Participants n=5 Participants	393 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	15 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants
Age, Continuous	48.6 years STANDARD_DEVIATION 12.32 • n=5 Participants	47.7 years STANDARD_DEVIATION 11.56 • n=7 Participants	49.1 years STANDARD_DEVIATION 10.37 • n=5 Participants	48.5 years STANDARD_DEVIATION 11.26 • n=4 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	143 Participants n=7 Participants	141 Participants n=5 Participants	355 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	28 Participants n=7 Participants	26 Participants n=5 Participants	69 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=5 Participants	159 Participants n=7 Participants	157 Participants n=5 Participants	398 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants	161 Participants n=7 Participants	159 Participants n=5 Participants	405 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 30

Population: The primary endpoint measurements were carried out using the Intent-To-Treat (ITT) analysis set, which was defined as all participants who were randomized. Multiple imputation method was used for missing variables in primary efficacy endpoint.

The outcome measured is the percentage of participants who had a ≥2-grade improvement from baseline LCL severity at maximum smile according to investigator and participant FWS ratings at Day 30.

Both the INVESTIGATOR AND PARTICIPANT evaluate the LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.

Outcome measures

Measure	Placebo n=86 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=171 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=167 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of LCL Severity at Maximum Smile at Day 30	0 Participants	35 Participants	38 Participants

SECONDARY outcome

Timeframe: Day 30

Population: All secondary efficacy analyses were carried out using the Intent-To-Treat (ITT) analysis subset, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.

The outcome here only considers the INVESTIGATOR assessments (excludes the participant assessment). The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. A Responder was defined as one achieving a ≥2-grade improvement from baseline at maximum smile at Day 30.

Outcome measures

Measure	Placebo n=80 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=164 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=166 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale With Photonumeric Guide (FWS)	0 Participants	59 Participants	64 Participants

SECONDARY outcome

Timeframe: Day 1 (first treatment) to Day 180

Population: All secondary efficacy analyses were carried out using the Intent-To-Treat (ITT) analysis subset, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data. The participant analyzed here corresponds to the responders in Outcome 2.

The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

Outcome measures

Measure	Placebo Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=59 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=64 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
The Duration of Lateral Canthal Lines (LCL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in LCL Severity at Maximum Smile at Day 30 According to Investigator Assessments Using the FWS	—	113 Days Interval 91.0 to 121.0	93 Days Interval 89.0 to 118.0

SECONDARY outcome

Timeframe: Day 60

Population: All secondary efficacy analyses were carried out using the Intent-To-Treat (ITT) analysis set or subset, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.

The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.

Outcome measures

Measure	Placebo n=75 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=158 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=156 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Lateral Canthal Lines (LCL)	8 Participants	97 Participants	122 Participants

SECONDARY outcome

Timeframe: Day 30

Population: All secondary efficacy analyses were carried out using the Intent-To-Treat (ITT) analysis subset, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.

The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.

Among Participants Who Were Rated At least Mild at Rest at Baseline, where a Responder was Defined as Achieving a ≥1-grade Improvement from Baseline at Day 30. The outcome measured here is the proportion of participants who achieved a ≥1-grade improvement from baseline LCL severity at rest based on investigator FWS rating.

Outcome measures

Measure	Placebo n=77 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=158 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=158 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)	13 Participants	106 Participants	107 Participants

SECONDARY outcome

Timeframe: AEs that started or worsen after the first dose of study intervention and within 30 days after the last dose.

Population: All safety analyses were carried out using the Safety population set or subset, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received.

This section focuses primarily on TEAEs, i.e., AEs that started or worsened after the first dose of study intervention and within 30 days after the last dose. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.

Outcome measures

Measure	Placebo n=86 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=171 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=168 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs)	50 Participants	90 Participants	106 Participants

SECONDARY outcome

Timeframe: Baseline to Day 360

Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.

The outcome reported here is the mean change in Systolic BP from baseline to study exit.

Outcome measures

Measure	Placebo n=73 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=149 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=157 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Mean Change From Baseline in Systolic Blood Pressure (BP)	1.0 mmHg Standard Deviation 11.60	-0.4 mmHg Standard Deviation 12.29	-0.3 mmHg Standard Deviation 13.67

SECONDARY outcome

Timeframe: Baseline to Day 360

Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.

The outcome reported here is the mean change in Diastolic BP from baseline to study exit.

Outcome measures

Measure	Placebo n=73 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=149 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=157 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Mean Change From Baseline in Diastolic Blood Pressure (BP)	-1.2 mmHg Standard Deviation 8.61	-1.4 mmHg Standard Deviation 8.34	-0.7 mmHg Standard Deviation 9.28

SECONDARY outcome

Timeframe: Baseline to Day 360

Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.

The outcome reported here is the mean change in Pulse Rate from baseline to study exit.

Outcome measures

Measure	Placebo n=73 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=149 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=157 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Mean Change From Baseline in Pulse Rate	-0.7 beats/min Standard Deviation 11.2	0.9 beats/min Standard Deviation 10.54	-0.4 beats/min Standard Deviation 11.34

SECONDARY outcome

Timeframe: Baseline to Day 360

Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.

The outcome reported here is the mean change in Respiratory Rate from baseline to study exit.

Outcome measures

Measure	Placebo n=73 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=149 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=157 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Mean Change From Baseline in Respiratory Rate	-0.4 breaths/min Standard Deviation 2.03	-0.3 breaths/min Standard Deviation 2.04	-0.6 breaths/min Standard Deviation 2.47

SECONDARY outcome

Timeframe: Baseline to Day 360

Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.

The outcome reported here is a mean change in mean heart rate from baseline to study exit.

Outcome measures

Measure	Placebo n=72 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=149 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=157 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate	3.3 beats/min Standard Deviation 10.34	4.2 beats/min Standard Deviation 9.35	2.7 beats/min Standard Deviation 8.34

SECONDARY outcome

Timeframe: Baseline to Day 360

Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.

The outcome reported here is a mean change in PR interval from baseline to study exit.

Outcome measures

Measure	Placebo n=71 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=149 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=157 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval	-0.5 milliseconds Standard Deviation 9.36	-0.7 milliseconds Standard Deviation 12.37	0.0 milliseconds Standard Deviation 11.09

SECONDARY outcome

Timeframe: Baseline to Day 360

Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.

The outcome reported here is a mean change in QRS duration from baseline to study exit.

Outcome measures

Measure	Placebo n=72 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=149 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=157 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration	0.0 milliseconds Standard Deviation 6.16	0.4 milliseconds Standard Deviation 5.35	1.6 milliseconds Standard Deviation 8.06

SECONDARY outcome

Timeframe: Baseline to Day 360

Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.

The outcome reported here is a mean change in QT interval from baseline to study exit.

Outcome measures

Measure	Placebo n=72 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=149 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=157 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval	-8.6 milliseconds Standard Deviation 25.07	-10.4 milliseconds Standard Deviation 21.96	-9.2 milliseconds Standard Deviation 21.26

SECONDARY outcome

Timeframe: Baseline to Day 360

Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.

The outcome reported here is a mean change in QTcB interval from baseline to study exit.

Outcome measures

Measure	Placebo n=72 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=149 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=157 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval	0.9 milliseconds Standard Deviation 17.34	1.6 milliseconds Standard Deviation 16.64	-1.5 milliseconds Standard Deviation 16.3

SECONDARY outcome

Timeframe: Baseline to Day 360

Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.

The outcome reported here is a mean change in QTcF interval from baseline to study exit.

Outcome measures

Measure	Placebo n=72 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=149 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=157 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval	-2.4 milliseconds Standard Deviation 14.21	-2.7 milliseconds Standard Deviation 13.57	-4.2 milliseconds Standard Deviation 13.65

SECONDARY outcome

Timeframe: Baseline to Day 360

Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.

The outcome reported here is a mean change in RR interval from baseline to study exit.

Outcome measures

Measure	Placebo n=72 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=149 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=157 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval	-42.6 milliseconds Standard Deviation 137.27	-53.0 milliseconds Standard Deviation 120.85	-35.0 milliseconds Standard Deviation 114.66

SECONDARY outcome

Timeframe: Baseline to Day 360

Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.

Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.

Outcome measures

Measure	Placebo n=72 Participants Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=145 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. .	MT10109L 24U + MT10109L 20U n=150 Participants MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Number of Participants With Binding and Neutralizing Antibodies	0 Participants	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 34 other events

Deaths: 0 deaths

MT10109L 24U + Placebo

Serious events: 11 serious events

Other events: 60 other events

Deaths: 0 deaths

MT10109L 24U + MT10109L 20U

Serious events: 5 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=86 participants at risk Placebo was injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=171 participants at risk MT10109L 24U was injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + MT10109L 20U n=168 participants at risk MT10109L 24U was injected into the LCL and MT10109L 20U into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Cardiac disorders Aortic valve incompetence	0.00% 0/86 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.58% 1/171 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/168 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Eye disorders Conjunctival haemorrhage	0.00% 0/86 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.58% 1/171 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/168 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Gastrointestinal disorders Colitis	1.2% 1/86 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.58% 1/171 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/168 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Gastrointestinal disorders Colitis microscopic	1.2% 1/86 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/171 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/168 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Immune system disorders Allergy to arthropod sting	0.00% 0/86 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/171 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.60% 1/168 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Infections and infestations Pneumonia	0.00% 0/86 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/171 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.60% 1/168 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Infections and infestations COVID-19	0.00% 0/86 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	1.2% 2/171 • Number of events 2 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/168 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Injury, poisoning and procedural complications Face injury	0.00% 0/86 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.58% 1/171 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/168 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/86 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.58% 1/171 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/168 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.2% 1/86 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	1.8% 3/171 • Number of events 3 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	1.2% 2/168 • Number of events 2 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/86 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/171 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.60% 1/168 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/86 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.58% 1/171 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/168 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/86 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.58% 1/171 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/168 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/86 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.58% 1/171 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/168 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Nervous system disorders Syncope	0.00% 0/86 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.58% 1/171 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/168 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Renal and urinary disorders Acute kidney injury	1.2% 1/86 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/171 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/168 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Surgical and medical procedures Abortion induced [F]	0.00% 0/71 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.70% 1/143 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	0.00% 0/141 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.

Other adverse events

Measure	Placebo n=86 participants at risk Placebo was injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + Placebo n=171 participants at risk MT10109L 24U was injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	MT10109L 24U + MT10109L 20U n=168 participants at risk MT10109L 24U was injected into the LCL and MT10109L 20U into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Nervous system disorders Headache	3.5% 3/86 • Number of events 3 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	5.3% 9/171 • Number of events 9 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	13.1% 22/168 • Number of events 22 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Infections and infestations Nasopharyngitis	7.0% 6/86 • Number of events 6 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	9.4% 16/171 • Number of events 16 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	8.9% 15/168 • Number of events 15 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
Infections and infestations Upper respiratory tract infection	5.8% 5/86 • Number of events 5 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	2.3% 4/171 • Number of events 4 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	6.0% 10/168 • Number of events 10 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
General disorders Injection site pain	9.3% 8/86 • Number of events 8 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	8.8% 15/171 • Number of events 15 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	8.9% 15/168 • Number of events 15 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
General disorders Injection site haemorrhage	7.0% 6/86 • Number of events 6 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	5.3% 9/171 • Number of events 9 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	3.6% 6/168 • Number of events 6 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.
General disorders Injection site bruising	7.0% 6/86 • Number of events 6 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	4.1% 7/171 • Number of events 7 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.	3.6% 6/168 • Number of events 6 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier) Treatment-emergent adverse events were classified according to MedDRA, Version 23.1.

Additional Information

Young Ryu

Medytox Inc.

Phone: +82-2-6901-5424

Email: aab005@medytox.com

Results disclosure agreements

• Principal investigator is a sponsor employee General research agreement between the sponsor and PI's that includes a confidentiality section that includes a statement that the sponsor is and shall remain the exclusive owner of 'Information'. ) 'Information' shall include, but shall not be limited to, protocols, trade secrets, know-how, formulations, inventions, techniques, equipment, data and results.
• Publication restrictions are in place

Restriction type: OTHER