Trial Outcomes & Findings for Intranasal Oxytocin for the Treatment of Alcohol Use Disorder (NCT NCT03878316)

Last Updated: 2025-08-07

Results Overview

The primary efficacy endpoint is the weekly percentage of heavy drinking days during the 10-week maintenance treatment period. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. Drinking data will be collected by the Timeline Followback (TLFB) method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

Weeks 3-12

Results posted on

2025-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Intranasal Oxytocin Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Overall Study STARTED	50	50
Overall Study COMPLETED	43	42
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Total n=97 Participants Total of all reporting groups
Age, Continuous	50.0 years STANDARD_DEVIATION 10.8 • n=5 Participants	51.1 years STANDARD_DEVIATION 10.1 • n=7 Participants	50.6 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	46 Participants n=7 Participants	88 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	42 Participants n=7 Participants	81 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants	48 participants n=7 Participants	97 participants n=5 Participants
Percentage of heavy drinking days	74.7 percentage of days STANDARD_DEVIATION 23.0 • n=5 Participants	79.8 percentage of days STANDARD_DEVIATION 21.5 • n=7 Participants	77.2 percentage of days STANDARD_DEVIATION 22.3 • n=5 Participants

PRIMARY outcome

Timeframe: Weeks 3-12

Population: Full Analysis Set - randomized and received study medication

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Weekly Percentage of Heavy Drinking Days	51.5 percentage of days per week Standard Error 3.9	52.9 percentage of days per week Standard Error 3.9

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received medication

Percentage of subjects with no heavy drinking days during the 10-week Maintenance period

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Percentage of Subjects With no Heavy Drinking Days	2.1 percentage of participants	6.3 percentage of participants

SECONDARY outcome

Timeframe: Weeks 3-12

Population: Full Analysis Set - randomized and received medication

Percentage of subjects abstinent from alcohol during the 10-week Maintenance period

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Percentage of Subjects Abstinent From Alcohol	0 percentage of participants	2.1 percentage of participants

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received study medication

Percentage of subjects with at least a 1-level World Health Organization (WHO) drinking risk category decrease from the baseline level to (the period including the 28 days before screening) to the level during the treatment phase (Study Weeks 3-12). The WHO levels of average alcohol consumption per day vary by Sex of participants and are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category.

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Percentage of Subjects With at Least a 1-level World Health Organization (WHO) Drinking Risk Category Decrease	59.6 percentage of participants	53.2 percentage of participants

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received study medication

Percentage of subjects with at least a 2-level World Health Organization (WHO) drinking risk category decrease from the baseline level to (the period including the 28 days before screening) to the level during the treatment phase (Study Weeks 3-12). The WHO levels of average alcohol consumption per day vary by Sex of participants and are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category.

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Percentage of Subjects With at Least a 2-level World Health Organization (WHO) Drinking Risk Category Decrease	23.4 percentage of participants	23.4 percentage of participants

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received study medication

Timeline Follow Back daily drinking data used to calculate the % of days abstinent per week during the 10-week Maintenance period.

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Percentage of Days Abstinent Per Week	23.2 percentage of days per week Standard Error 2.5	22.6 percentage of days per week Standard Error 2.5

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received medication

Weekly mean number of drinks per week during the 10-week Maintenance period.

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Weekly Mean Number of Drinks Per Week	33.1 standard drinking units (SDUs) per week Standard Error 2.2	34.7 standard drinking units (SDUs) per week Standard Error 2.3

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received medication

Weekly mean drinks per drinking day during the 10-week Maintenance period.

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Weekly Mean Drinks Per Drinking Day	6.2 standard drinking units (SDUs) per week Standard Error 0.3	6.3 standard drinking units (SDUs) per week Standard Error 0.3

SECONDARY outcome

Timeframe: week 13

Population: Full Analysis Set - randomized and received medication

The MINI (paper version 7.0.2) is a short structured diagnostic interview, developed jointly by psychiatrists and clinicians in the United States and Europe, for DSM-5 and ICD-10 psychiatric disorders (Sheehan-1998). This scale is a count of the number of alcohol use disorder symptoms. Minimum = 0 and maximum=11. Higher scores indicate worse outcome.

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Number of Alcohol Use Disorder Symptoms (MINI)	3.9 Number of alcohol use disorder symptoms Standard Error 0.3	4.2 Number of alcohol use disorder symptoms Standard Error 0.3

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received medication

Cigarettes smoked per week among smokers during the 10-week Maintenance period.

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=4 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=7 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Cigarettes Smoked Per Week Among Smokers	40.6 number of cigarettes smoked per week Standard Deviation 32.1	45.9 number of cigarettes smoked per week Standard Deviation 52.8

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received medication

Abstinence from cigarette smoking among smokers during the 10-week Maintenance period.

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=4 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=7 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Abstinence From Cigarette Smoking Among Smokers	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received medication

Other nicotine product use - days per week among other nicotine product users during the Maintenance period

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=4 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=8 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Other Nicotine Product Use - Days Per Week Among Other Nicotine Product Users	4.9 days per week Standard Deviation 1.9	5.4 days per week Standard Deviation 2.3

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received medication

Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) scores (attachment-related anxiety subscale) during the 10-week Maintenance period. Minimum = 0 and maximum = 126. Higher scores are worse outcome.

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) Scores (Attachment-related Anxiety Subscale)	2.4 score on a scale Standard Error 0.1	2.4 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received study medication

PROMIS® (Patient-Reported Outcomes Measurement Information System) Sleep Disturbances score (Short Form 8b) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more sleep disturbance).

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
PROMIS Sleep Disturbances Score	51.0 T-score Standard Error 0.7	51.3 T-score Standard Error 0.7

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received medication

PROMIS® (Patient-Reported Outcomes Measurement Information System) alcohol-related negative consequences score (Long Form) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more alcohol-related negative consequences).

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
PROMIS Alcohol-related Negative Consequences Score	48.5 T-score Standard Error 0.6	47.7 T-score Standard Error 0.6

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received medication

PROMIS® (Patient-Reported Outcomes Measurement Information System) Pain Interference score (Short Form 8a) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more pain interference).

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
PROMIS Pain Interference Score	52.2 T-score Standard Error 1.0	52.5 T-score Standard Error 1.0

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received medication

Profile of Moods States (POMS) - Total Mood Disturbance during the 10-week Maintenance period. Minimum = -32 and maximum = 200. Higher scores are worse outcome.

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Profile of Moods States (POMS) - Total Mood Disturbance	8.9 score on a scale Standard Error 2.4	7.6 score on a scale Standard Error 2.4

SECONDARY outcome

Timeframe: weeks 3-12

Population: Full Analysis Set - randomized and received medication

Urge to Drink alcohol craving score during the 10-week Maintenance period. Minimum = 0 and maximum = 35. Higher scores are worse outcome.

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin n=49 Participants Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 Participants Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Urge to Drink Alcohol Craving Score	13.6 score on a scale Standard Error 0.7	13.2 score on a scale Standard Error 0.7

Adverse Events

Intranasal Oxytocin

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Instrasal Placebo

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Daniel Falk

National Institute on Alcohol Abuse and Alcoholism

Phone: 301-443-0788

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Intranasal Oxytocin n=49 participants at risk Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose	Instrasal Placebo n=48 participants at risk Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Cardiac disorders Bradycardia	8.2% 4/49 • Number of events 5 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Cardiac disorders Palpitations	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Cardiac disorders Tachycardia	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	4.2% 2/48 • Number of events 2 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Ear and labyrinth disorders Ear pain	0.00% 0/49 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	2.1% 1/48 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Ear and labyrinth disorders Tinnitus	0.00% 0/49 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	2.1% 1/48 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Eye disorders Dry eye	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Eye disorders Eye irritation	0.00% 0/49 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	2.1% 1/48 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Gastrointestinal disorders Abdominal hernia	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Gastrointestinal disorders Diarrhoea	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	6.2% 3/48 • Number of events 4 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Gastrointestinal disorders Dry mouth	0.00% 0/49 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	2.1% 1/48 • Number of events 2 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Gastrointestinal disorders Dyspepsia	0.00% 0/49 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	2.1% 1/48 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Gastrointestinal disorders Nausea	8.2% 4/49 • Number of events 4 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	2.1% 1/48 • Number of events 2 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Gastrointestinal disorders Vomiting	6.1% 3/49 • Number of events 3 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	2.1% 1/48 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Gastrointestinal disorders Abdominal pain upper	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	2.1% 1/48 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
General disorders Chest Pain	0.00% 0/49 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	2.1% 1/48 • Number of events 2 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
General disorders Chills	0.00% 0/49 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	4.2% 2/48 • Number of events 3 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
General disorders Fatigue	0.00% 0/49 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	4.2% 2/48 • Number of events 2 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
General disorders Mucosal haemorrhage	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
General disorders Pain	0.00% 0/49 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	4.2% 2/48 • Number of events 2 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
General disorders Pain and discomfort NEC	0.00% 0/49 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	2.1% 1/48 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
General disorders Pyrexia	4.1% 2/49 • Number of events 3 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
General disorders Secretion discharge	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
General disorders Sensation of foreign body	0.00% 0/49 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	2.1% 1/48 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Infections and infestations Bacterial infection	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Infections and infestations Bronchitis	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Infections and infestations COVID-19	4.1% 2/49 • Number of events 2 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	4.2% 2/48 • Number of events 2 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Infections and infestations Diverticulitis	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Infections and infestations Influenza	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Infections and infestations Nasopharyngitis	18.4% 9/49 • Number of events 9 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	6.2% 3/48 • Number of events 3 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Infections and infestations Pharyngitis streptococcal	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Infections and infestations Sinusitis	0.00% 0/49 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	2.1% 1/48 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Infections and infestations Upper respiratory tract infection	4.1% 2/49 • Number of events 2 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	6.2% 3/48 • Number of events 3 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Infections and infestations Urinary tract infection	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Infections and infestations Viral infection	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Injury, poisoning and procedural complications Arthropod bite	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Injury, poisoning and procedural complications Foot fracture	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Injury, poisoning and procedural complications Post procedural haemorrhage	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Injury, poisoning and procedural complications Procedural pain	2.0% 1/49 • Number of events 1 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Injury, poisoning and procedural complications Skin laceration	2.0% 1/49 • Number of events 3 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	0.00% 0/48 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
Investigations Alanine aminotransferase increased	10.2% 5/49 • Number of events 8 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"	10.4% 5/48 • Number of events 6 • AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15. General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"