An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.

Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.

Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

ISRs were recorded via ISR diaries and managed through investigator assessment. The participants who experienced any injection site reaction were reported.

Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.

Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.

Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.

Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.

Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for pharmacokinetic (PK) analysis of VH3810109.

Analysis was performed on PK Parameter Analysis Set, which included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.

Analysis was performed on PK Parameter Analysis Set, which included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.

Analysis was performed on PK Parameter Analysis Set, which included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.

Analysis was performed on PK Parameter Analysis Set, which included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.

Analysis was performed on PK Parameter Analysis Set, which included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.

Analysis was performed on the Safety Set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial.

Scores range from 1 to 5; the scores are defined as following: 1=not at all bothered, 2=a little bothered, 3=moderately bothered, 4=very bothered, 5=extremely bothered; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.

Analysis was performed on the Safety Set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial.

Scores range from 1 to 5; the scores are defind as following: 1=totaly acceptable, 2=very acceptable, 3=moderately acceptable, 4=a little acceptable, 5=not at all acceptable; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.

Analysis was performed on the Safety Set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

Post-injection assessment of pain was measured based on NRS which is a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).

Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

Post-injection assessment of pain was measured based on NRS which is a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).

Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

ISRs were recorded via ISR diaries and managed through investigator assessment. Severity of injection site reactions was analyzed using DAIDS AE Grading Table. The severity was categorized into grades as following: Grade 1 (mild): causing no or minimal interference with usual social and functional activities, Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated, Grade 5 (death). Higher grade indicates more severe condition.

Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

ISRs will be recorded via ISR diaries and managed through investigator assessment.

Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assesseed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Urine samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109. At baseline and post-baseline, worst case urinalysis data was determined by comparing the resulted values of the urinalysis for each participant to the normal rage. This endpoint evaluates the changes from baseline for the worst case urinalysis.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

ECG values were collected as assessed by protocol, at the indicated time points.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Temperature was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Pulse rate was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Respiratory rate was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Blood pressure was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.

Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assesses timepoints and analysis.