Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults (NCT NCT05292391)

NCT ID: NCT05292391

Last Updated: 2025-07-14

Results Overview

An AE or suspected adverse reaction were considered an SAE if, in the view of either the principal investigator or the sponsor, resulted in any of the following outcomes: * Death, * A life-threatening AE, * Inpatient hospitalization or prolongation of existing hospitalization, * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or * A congenital anomaly/birth defect. * Important medical events that may not have resulted in death, been life-threatening, or required hospitalizations could have been considered serious when, based upon appropriate medical judgment they could have jeopardized the patient or participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 45 participants
• Primary outcome timeframe: Through 12 months after the last study vaccination. For Groups A, B, D, E: Day 1 through Day 422. For Group C: Day 1 through Day 545
• Results posted on: 2025-07-14

Participant Flow

The study population includes 45 healthy adults ages 18 through 55 years who met all eligibility criteria. Participants were enrolled between 23May2022 to 24Jan2023.

Participant milestones

Measure	Group A: 100 ug Sm-p80 Unadjuvanted 0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57. Sm-p80: The Sm-p80 protein is formulated and lyophilized to yield the vaccine antigen, Sm-p80 for Injection.	Group B: 10 ug Sm-p80 + GLA-SE 0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57. Sm-p80 + GLA-SE: Combination vaccine containing Sm-p80 antigen and GLA-SE adjuvant.	Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180. Sm-p80 + GLA-SE: Combination vaccine containing Sm-p80 antigen and GLA-SE adjuvant.	Group D: 30 ug Sm-p80 + GLA-SE 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57. Sm-p80 + GLA-SE: Combination vaccine containing Sm-p80 antigen and GLA-SE adjuvant.	Group E: 100 ug Sm-p80 + GLA-SE 0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57. Sm-p80 + GLA-SE: Combination vaccine containing Sm-p80 antigen and GLA-SE adjuvant.
Overall Study STARTED	9	9	9	9	9
Overall Study COMPLETED	9	9	9	8	9
Overall Study NOT COMPLETED	0	0	0	1	0

Reasons for withdrawal

Measure	Group A: 100 ug Sm-p80 Unadjuvanted 0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57. Sm-p80: The Sm-p80 protein is formulated and lyophilized to yield the vaccine antigen, Sm-p80 for Injection.	Group B: 10 ug Sm-p80 + GLA-SE 0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57. Sm-p80 + GLA-SE: Combination vaccine containing Sm-p80 antigen and GLA-SE adjuvant.	Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180. Sm-p80 + GLA-SE: Combination vaccine containing Sm-p80 antigen and GLA-SE adjuvant.	Group D: 30 ug Sm-p80 + GLA-SE 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57. Sm-p80 + GLA-SE: Combination vaccine containing Sm-p80 antigen and GLA-SE adjuvant.	Group E: 100 ug Sm-p80 + GLA-SE 0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57. Sm-p80 + GLA-SE: Combination vaccine containing Sm-p80 antigen and GLA-SE adjuvant.
Overall Study Lost to Follow-up	0	0	0	1	0

Baseline Characteristics

Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults

Baseline characteristics by cohort

Measure	Group A: 100 ug Sm-p80 Unadjuvanted n=9 Participants 0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57.	Group B: 10 ug Sm-p80 + GLA-SE n=9 Participants 0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180.	Group D: 30 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group E: 100 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57.	Total n=45 Participants Total of all reporting groups
Age, Continuous	38.9 years STANDARD_DEVIATION 8.2 • n=5 Participants	40.8 years STANDARD_DEVIATION 10.0 • n=7 Participants	35.4 years STANDARD_DEVIATION 7.3 • n=5 Participants	34.0 years STANDARD_DEVIATION 9.9 • n=4 Participants	38.8 years STANDARD_DEVIATION 13.0 • n=21 Participants	37.6 years STANDARD_DEVIATION 9.8 • n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	26 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	19 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	8 Participants n=21 Participants	42 Participants n=8 Participants
Ethnicity (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	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 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	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	8 Participants n=21 Participants	38 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 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	0 Participants n=21 Participants	0 Participants n=8 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	9 participants n=5 Participants	9 participants n=4 Participants	9 participants n=21 Participants	45 participants n=8 Participants
Height	169.58 cm STANDARD_DEVIATION 6.23 • n=5 Participants	175.19 cm STANDARD_DEVIATION 7.50 • n=7 Participants	168.14 cm STANDARD_DEVIATION 9.28 • n=5 Participants	166.62 cm STANDARD_DEVIATION 5.67 • n=4 Participants	171.33 cm STANDARD_DEVIATION 6.63 • n=21 Participants	170.17 cm STANDARD_DEVIATION 7.46 • n=8 Participants
Weight	75.62 kg STANDARD_DEVIATION 13.94 • n=5 Participants	77.89 kg STANDARD_DEVIATION 10.35 • n=7 Participants	72.81 kg STANDARD_DEVIATION 11.38 • n=5 Participants	73.59 kg STANDARD_DEVIATION 12.40 • n=4 Participants	71.68 kg STANDARD_DEVIATION 13.27 • n=21 Participants	74.32 kg STANDARD_DEVIATION 11.97 • n=8 Participants
BMI	26.27 kg/m^2 STANDARD_DEVIATION 4.34 • n=5 Participants	25.29 kg/m^2 STANDARD_DEVIATION 2.00 • n=7 Participants	25.72 kg/m^2 STANDARD_DEVIATION 3.38 • n=5 Participants	26.46 kg/m^2 STANDARD_DEVIATION 3.99 • n=4 Participants	24.39 kg/m^2 STANDARD_DEVIATION 4.06 • n=21 Participants	25.62 kg/m^2 STANDARD_DEVIATION 3.56 • n=8 Participants

PRIMARY outcome

Timeframe: Through 12 months after the last study vaccination. For Groups A, B, D, E: Day 1 through Day 422. For Group C: Day 1 through Day 545

Population: The safety population includes all participants who received at least one dose of the study product and is summarized according to treatment received.

An AE or suspected adverse reaction were considered an SAE if, in the view of either the principal investigator or the sponsor, resulted in any of the following outcomes:

• Death,
• A life-threatening AE,
• Inpatient hospitalization or prolongation of existing hospitalization,
• A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or
• A congenital anomaly/birth defect.
• Important medical events that may not have resulted in death, been life-threatening, or required hospitalizations could have been considered serious when, based upon appropriate medical judgment they could have jeopardized the patient or participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.

Outcome measures

Measure	Group A: 100 ug Sm-p80 Unadjuvanted n=9 Participants 0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57.	Group B: 10 ug Sm-p80 + GLA-SE n=9 Participants 0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180.	Group D: 30 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group E: 100 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57.
Number of Participants Reporting Serious Adverse Events (SAEs) Throughout the Study	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: For Groups A, B, D, E: Post Dose 1 Day 1 through Day 8, Post Dose 2 Day 29 through Day 36, Post Dose 3 Day 57 through 64. For Group C: Post Dose 1 Day 1 through Day 8, Post Dose 2 Day 29 through 36, Post Dose 3 Day 180 through Day 187.

Population: The safety population includes all participants who received at least one dose of the study product and is summarized according to treatment received.

Systemic symptoms collected include arthralgia, chills, fatigue, fever, headache, malaise, myalgia, nausea, and vomiting.

Injection site (local) symptoms collected include erythema/redness (measurement), induration/swelling (functional and measurement), pain, pruritus, and tenderness

Outcome measures

Measure	Group A: 100 ug Sm-p80 Unadjuvanted n=9 Participants 0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57.	Group B: 10 ug Sm-p80 + GLA-SE n=9 Participants 0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180.	Group D: 30 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group E: 100 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57.
Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose Post Dose 1	9 Participants	9 Participants	8 Participants	5 Participants	9 Participants
Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose Post Dose 2	9 Participants	7 Participants	8 Participants	7 Participants	6 Participants
Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose Post Dose 3	8 Participants	9 Participants	9 Participants	7 Participants	7 Participants

PRIMARY outcome

Timeframe: Through 28 days after each study vaccination. For Groups A, B, D, E: Day 1 through Day 85. For Group C: Day 1 through Day 57, Day 180 through Day 208

Population: The safety population includes all participants who received at least one dose of the study product and is summarized according to treatment received.

Chemistry measurements collected include alanine aminotransferase (ALT) and creatinine.

Labs were collected on vaccination days and 7 days and 28 days post each vaccination.

Outcome measures

Measure	Group A: 100 ug Sm-p80 Unadjuvanted n=9 Participants 0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57.	Group B: 10 ug Sm-p80 + GLA-SE n=9 Participants 0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180.	Group D: 30 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group E: 100 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57.
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 1 · No events	9 Participants	9 Participants	8 Participants	9 Participants	9 Participants
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 1 · Mild events	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 8 · No events	9 Participants	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 8 · Mild events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 29 · No events	9 Participants	9 Participants	9 Participants	8 Participants	9 Participants
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 29 · Mild events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 36 · No events	8 Participants	9 Participants	9 Participants	8 Participants	8 Participants
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 36 · Mild events	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 57 · No events	9 Participants	9 Participants	9 Participants	9 Participants	8 Participants
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 57 · Mild events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 64 · No events	9 Participants	9 Participants	—	8 Participants	8 Participants
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 64 · Mild events	0 Participants	0 Participants	—	0 Participants	0 Participants
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 85 · No events	8 Participants	9 Participants	0 Participants	7 Participants	8 Participants
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 85 · Mild events	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 180 · Mild events	—	—	0 Participants	—	—
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 187 · No events	—	—	9 Participants	—	—
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 187 · Mild events	—	—	0 Participants	—	—
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 208 · No events	—	—	9 Participants	—	—
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 208 · Mild events	—	—	0 Participants	—	—
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 180 · No events	—	—	9 Participants	—	—

PRIMARY outcome

Timeframe: Through 28 days after each study vaccination. For Groups A, B, D, E: Day 1 through Day 85. For Group C: Day 1 through Day 57, Day 180 through Day 208

Population: The safety population includes all participants who received at least one dose of the study product and is summarized according to treatment received.

Hematology measurements include white blood cells (WBC), hemoglobin, and platelets.

Labs were collected on vaccination days and 7 days and 28 days post each vaccination.

Outcome measures

Measure	Group A: 100 ug Sm-p80 Unadjuvanted n=9 Participants 0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57.	Group B: 10 ug Sm-p80 + GLA-SE n=9 Participants 0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180.	Group D: 30 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group E: 100 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57.
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 1 · No events	9 Participants	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 1 · Mild or Moderate Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 8 · No events	8 Participants	6 Participants	9 Participants	9 Participants	8 Participants
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 8 · Mild or Moderate Events	0 Participants	3 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 29 · No events	8 Participants	9 Participants	9 Participants	8 Participants	8 Participants
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 29 · Mild or Moderate Events	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 36 · No events	9 Participants	8 Participants	9 Participants	8 Participants	7 Participants
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 36 · Mild or Moderate Events	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 57 · No events	9 Participants	9 Participants	7 Participants	9 Participants	7 Participants
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 57 · Mild or Moderate Events	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 64 · No events	9 Participants	8 Participants	—	8 Participants	6 Participants
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 64 · Mild or Moderate Events	0 Participants	1 Participants	—	0 Participants	2 Participants
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 85 · No events	8 Participants	7 Participants	—	7 Participants	8 Participants
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 85 · Mild or Moderate Events	0 Participants	2 Participants	—	1 Participants	0 Participants
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 180 · No events	—	—	9 Participants	—	—
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 180 · Mild or Moderate Events	—	—	0 Participants	—	—
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 187 · No events	—	—	9 Participants	—	—
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 187 · Mild or Moderate Events	—	—	0 Participants	—	—
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 208 · No events	—	—	8 Participants	—	—
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose Day 208 · Mild or Moderate Events	—	—	1 Participants	—	—

PRIMARY outcome

Timeframe: Through 28 days after each study vaccination. For Groups A, B, D, E: Day 1 through Day 85. For Group C: Day 1 through Day 57, Day 180 through Day 208

Population: The safety population includes all participants who received at least one dose of the study product and is summarized according to treatment received.

Unsolicited adverse events (AEs) were defined as an untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Unsolicited AEs do not include solicited events that began within the reactogenicity period (7 days post dose).

Outcome measures

Measure	Group A: 100 ug Sm-p80 Unadjuvanted n=9 Participants 0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57.	Group B: 10 ug Sm-p80 + GLA-SE n=9 Participants 0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180.	Group D: 30 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group E: 100 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57.
Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose Related Mild Events	1 participants	2 participants	0 participants	1 participants	3 participants
Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose Related Moderate Events	1 participants	1 participants	0 participants	1 participants	0 participants
Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose Related Severe Events	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose Not Related Mild Events	3 participants	6 participants	2 participants	6 participants	2 participants
Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose Not Related Moderate Events	6 participants	1 participants	7 participants	0 participants	3 participants
Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose Not Related Severe Events	0 participants	0 participants	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: Through 12 months after the last study vaccination. For Groups A, B, D, E: Day 1 through Day 422. For Group C: Day 1 through Day 545

Population: The safety population includes all participants who received at least one dose of the study product and is summarized according to treatment received.

SAEs were AEs that resulted in any of the following: Death, Life-threatening, Hospitalization, Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, Congenital anomaly/birth defect. Important medical events based upon appropriate medical judgment they could have jeopardized the participant and may have required intervention to prevent one of the outcomes listed. MAAEs were hospitalization, ER visit, or an otherwise unscheduled visit to or from medical personnel for any reason and considered related to study product. NOCMCs were any new ICD-10 diagnosis that applied to the participant during the duration of the study, after receipt of the study agent, that was expected to continue for at least 3 months and require continued health care intervention. PIMMCs were AEs that include diseases which are clearly autoimmune in etiology and other inflammatory and/or neurologic disorders which may or may not have autoimmune etiologies.

Outcome measures

Measure	Group A: 100 ug Sm-p80 Unadjuvanted n=9 Participants 0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57.	Group B: 10 ug Sm-p80 + GLA-SE n=9 Participants 0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180.	Group D: 30 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group E: 100 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57.
Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) MAAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) NOCMC	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs) PIMMC	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Through 28 days after the first, second, and third study vaccinations. For Groups A, B, D, E: Day 8, 29, 36, 57, 64, and Day 85. For Group C: Day 8, 29, 36, 57, 180, 187, and Day 208.

Population: The modified intention-to-treat (mITT) immunogenicity population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.

Seroconversion was defined as a fourfold rise from baseline.

Outcome measures

Measure	Group A: 100 ug Sm-p80 Unadjuvanted n=9 Participants 0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57.	Group B: 10 ug Sm-p80 + GLA-SE n=9 Participants 0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180.	Group D: 30 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group E: 100 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57.
Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose Day 8	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose Day 29	1 Participants	0 Participants	2 Participants	1 Participants	2 Participants
Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose Day 36	4 Participants	6 Participants	8 Participants	7 Participants	8 Participants
Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose Day 57	5 Participants	8 Participants	8 Participants	7 Participants	8 Participants
Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose Day 64	8 Participants	9 Participants	—	7 Participants	8 Participants
Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose Day 85	8 Participants	9 Participants	—	7 Participants	8 Participants
Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose Day 180	—	—	6 Participants	—	—
Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose Day 187	—	—	8 Participants	—	—
Number of Participants Achieving Seroconversion in Sm-p80 IgG Antibodies 28 Days Post Each Dose Day 208	—	—	8 Participants	—	—

SECONDARY outcome

Timeframe: Through 7 and 28 days after each vaccination, and at 124 days after the last vaccination. For Groups A, B, D, E: Day 1, Day 8, 29, 36, 57, 64, 85, and Day 181. For Group C: Day 1, Day 8, 29, 36, 57, 180, 187, 208, and Day 304.

Population: The modified intention-to-treat (mITT) immunogenicity population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.

Geometric mean titers (GMTs).

Outcome measures

Measure	Group A: 100 ug Sm-p80 Unadjuvanted n=9 Participants 0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57.	Group B: 10 ug Sm-p80 + GLA-SE n=9 Participants 0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180.	Group D: 30 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group E: 100 ug Sm-p80 + GLA-SE n=9 Participants 0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57.
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 Day 1 (Pre-Dose 1)	24.659 titer of serum antibodies Interval 9.006 to 67.515	29.209 titer of serum antibodies Interval 13.278 to 64.256	74.704 titer of serum antibodies Interval 19.641 to 284.138	29.884 titer of serum antibodies Interval 9.794 to 91.185	26.235 titer of serum antibodies Interval 15.64 to 44.008
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 Day 8	22.668 titer of serum antibodies Interval 11.176 to 45.978	26.915 titer of serum antibodies Interval 11.785 to 61.469	66.900 titer of serum antibodies Interval 16.501 to 271.23	28.233 titer of serum antibodies Interval 8.652 to 92.135	16.887 titer of serum antibodies Interval 7.941 to 35.908
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 Day 29	32.515 titer of serum antibodies Interval 11.989 to 88.182	34.058 titer of serum antibodies Interval 11.83 to 98.049	139.103 titer of serum antibodies Interval 31.427 to 615.702	44.900 titer of serum antibodies Interval 10.445 to 193.011	49.354 titer of serum antibodies Interval 29.289 to 83.162
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 Day 36	120.194 titer of serum antibodies Interval 37.282 to 387.497	226.177 titer of serum antibodies Interval 85.98 to 594.975	1079.771 titer of serum antibodies Interval 406.714 to 2866.647	489.783 titer of serum antibodies Interval 136.234 to 1760.843	420.482 titer of serum antibodies Interval 159.039 to 1111.705
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 Day 57	228.496 titer of serum antibodies Interval 91.931 to 567.934	868.743 titer of serum antibodies Interval 249.759 to 3021.767	2691.534 titer of serum antibodies Interval 1022.427 to 7085.447	868.512 titer of serum antibodies Interval 114.784 to 6571.573	1659.587 titer of serum antibodies Interval 538.253 to 5116.973
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 Day 64	498.632 titer of serum antibodies Interval 233.502 to 1064.803	1475.325 titer of serum antibodies Interval 528.085 to 4121.657	—	4062.047 titer of serum antibodies Interval 551.805 to 29902.258	3620.347 titer of serum antibodies Interval 1234.793 to 10614.663
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 Day 85	1186.982 titer of serum antibodies Interval 367.503 to 3833.783	4254.894 titer of serum antibodies Interval 1788.09 to 10124.837	—	4073.814 titer of serum antibodies Interval 589.783 to 28139.074	4479.711 titer of serum antibodies Interval 1703.143 to 11782.807
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 Day 180	—	—	376.322 titer of serum antibodies Interval 113.17 to 1251.378	—	—
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 Day 181	514.170 titer of serum antibodies Interval 175.85 to 1503.385	1412.534 titer of serum antibodies Interval 626.88 to 3182.829	—	439.870 titer of serum antibodies Interval 105.239 to 1838.54	985.714 titer of serum antibodies Interval 364.226 to 2667.659
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 Day 187	—	—	2610.156 titer of serum antibodies Interval 844.732 to 8065.173	—	—
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 Day 208	—	—	16343.056 titer of serum antibodies Interval 5920.195 to 45115.994	—	—
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies 7 Days and 28 Days Post Each Dose and 124 Days Post Dose 3 Day 304	—	—	1471.551 titer of serum antibodies Interval 457.904 to 4729.075	—	—

Adverse Events

Group A: 100 ug Sm-p80 Unadjuvanted

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Group B: 10 ug Sm-p80 + GLA-SE

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Group D: 30 ug Sm-p80 + GLA-SE

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Group E: 100 ug Sm-p80 + GLA-SE

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group A: 100 ug Sm-p80 Unadjuvanted n=9 participants at risk 0.5 mL of 100 micrograms of Sm-p80 administered intramuscularly on Days 1, 29, and 57.	Group B: 10 ug Sm-p80 + GLA-SE n=9 participants at risk 0.5 mL of 10 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group C: 30 ug Sm-p80 + GLA-SE Delayed Booster n=9 participants at risk 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 180.	Group D: 30 ug Sm-p80 + GLA-SE n=9 participants at risk 0.5mL of 30 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57.	Group E: 100 ug Sm-p80 + GLA-SE n=9 participants at risk 0.5mL of 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29 and 57.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Cardiac disorders Tachycardia	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Ear and labyrinth disorders Tinnitus	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Endocrine disorders Thyroid mass	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Gastrointestinal disorders Abdominal pain upper	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Gastrointestinal disorders Nausea	11.1% 1/9 • Number of events 6 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	44.4% 4/9 • Number of events 4 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 4 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	33.3% 3/9 • Number of events 5 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Gastrointestinal disorders Vomiting	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Chills	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 6 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Fatigue	88.9% 8/9 • Number of events 16 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	55.6% 5/9 • Number of events 6 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	77.8% 7/9 • Number of events 16 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	66.7% 6/9 • Number of events 7 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	55.6% 5/9 • Number of events 15 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Influenza like illness	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Injection site bruising	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	33.3% 3/9 • Number of events 3 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Injection site erythema	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Injection site haematoma	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Injection site haemorrhage	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Injection site pain	100.0% 9/9 • Number of events 26 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	88.9% 8/9 • Number of events 22 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	100.0% 9/9 • Number of events 22 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	88.9% 8/9 • Number of events 18 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	100.0% 9/9 • Number of events 20 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Injection site pruritus	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Injection site swelling	33.3% 3/9 • Number of events 5 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Injection site vesicles	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Injection site warmth	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Malaise	33.3% 3/9 • Number of events 4 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	33.3% 3/9 • Number of events 4 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	55.6% 5/9 • Number of events 6 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	33.3% 3/9 • Number of events 6 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	44.4% 4/9 • Number of events 6 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Pain	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Pyrexia	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Swelling face	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Vessel puncture site bruise	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Vessel puncture site haemorrhage	33.3% 3/9 • Number of events 4 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
General disorders Vessel puncture site pain	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Infections and infestations COVID-19	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Infections and infestations Folliculitis	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Infections and infestations Herpes zoster	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Infections and infestations Hordeolum	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Infections and infestations Pharyngitis	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Infections and infestations Sinusitis	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Infections and infestations Upper respiratory tract infection	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	33.3% 3/9 • Number of events 3 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Injury, poisoning and procedural complications Sunburn	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Investigations Blood creatinine increased	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Investigations Blood pressure diastolic increased	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Investigations Haemoglobin decreased	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 5 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Investigations Platelet count increased	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 6 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Investigations Serum ferritin decreased	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Investigations White blood cell count decreased	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 3/9 • Number of events 8 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Musculoskeletal and connective tissue disorders Myalgia	66.7% 6/9 • Number of events 10 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	66.7% 6/9 • Number of events 11 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	44.4% 4/9 • Number of events 6 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	44.4% 4/9 • Number of events 5 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Musculoskeletal and connective tissue disorders Pain in extremity	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Musculoskeletal and connective tissue disorders Plantar fasciitis	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Musculoskeletal and connective tissue disorders Tendon disorder	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Nervous system disorders Dizziness	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 3 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Nervous system disorders Dysaesthesia	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Nervous system disorders Headache	66.7% 6/9 • Number of events 12 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	66.7% 6/9 • Number of events 11 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	77.8% 7/9 • Number of events 17 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	55.6% 5/9 • Number of events 7 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 4 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Nervous system disorders Hypoaesthesia	11.1% 1/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Nervous system disorders Presyncope	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Nervous system disorders Tension headache	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Psychiatric disorders Anxiety	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Psychiatric disorders Stress	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract irritation	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Skin and subcutaneous tissue disorders Dermatitis contact	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Skin and subcutaneous tissue disorders Erythema	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Skin and subcutaneous tissue disorders Papule	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Skin and subcutaneous tissue disorders Pruritus	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Skin and subcutaneous tissue disorders Urticaria	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Vascular disorders Hypertension	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 1 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.
Vascular disorders Systolic hypertension	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	22.2% 2/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	0.00% 0/9 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.	11.1% 1/9 • Number of events 2 • Serious adverse events (SAEs), MAAEs, NOCMCs, and PIMMCs were collected from the time of first study product injection through approximately 12 months after the last study product injection. Solicited AEs were collected from the time of each study product injection through 7 days after each study product injection. Unsolicited AEs were collected from the time of each study product injection through 28 days after the study product injection.

Additional Information

Lisa A. Jackson, MD, MPH

Kaiser Permanente Washington Health Research Institute

Phone: (206)-442-5216

Email: Lisa.A.Jackson@kp.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60