Trial Outcomes & Findings for Study to Evaluate Changes in Smokers Using on!® Nicotine Pouches (NCT NCT05664672)
NCT ID: NCT05664672
Last Updated: 2024-12-09
Results Overview
Summary of 24-hour urinary creatinine-adjusted total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
149 participants
Primary outcome timeframe
Samples collected over 24 hours on Day -1 (baseline) and Day 7
Results posted on
2024-12-09
Participant Flow
After screening, subjects who met eligibility criteria but were not needed once sample size objectives were met, were discontinued. The remaining subjects participated in a brief Product Use Trial to allow them to become accustomed to the products prior to randomization. Subjects who did not meet the randomization criteria after completing the Product Use Trial were discontinued; these subjects are included in the safety population but were not assigned to a study group.
Participant milestones
| Measure |
Not Assigned
Only includes subjects that enrolled in the study but dropped prior to randomization. This group includes subjects who participated in the Product Trial Period but withdrew before randomization.
|
Group 1 (CC)
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
Group 3 (NP4)
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
29
|
28
|
30
|
30
|
29
|
|
Overall Study
COMPLETED
|
0
|
28
|
25
|
30
|
25
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
3
|
0
|
5
|
7
|
Reasons for withdrawal
| Measure |
Not Assigned
Only includes subjects that enrolled in the study but dropped prior to randomization. This group includes subjects who participated in the Product Trial Period but withdrew before randomization.
|
Group 1 (CC)
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
Group 3 (NP4)
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
3
|
0
|
5
|
6
|
|
Overall Study
Failure to Meet Randomization Criteria
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Met Eligibility Criteria But Not Needed
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
The Fagerström Test for Cigarette Dependence was completed on the morning of Day 1 before any study product use. Subjects in the 'Not Assigned' group were discontinued prior to administration of the Fagerström Test and, therefore, the 'Number Analyzed' for this group is '0'.
Baseline characteristics by cohort
| Measure |
Not Assigned
n=2 Participants
Only include subjects that enrolled in the study but dropped prior to randomization. This group includes subjects who participated in the Product Trial Period but withdrew before randomization.
|
Group 1 (CC)
n=29 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=28 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=30 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=29 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 12.73 • n=2 Participants
|
34.2 years
STANDARD_DEVIATION 7.51 • n=29 Participants
|
33.6 years
STANDARD_DEVIATION 6.73 • n=28 Participants
|
35.9 years
STANDARD_DEVIATION 8.49 • n=30 Participants
|
31.7 years
STANDARD_DEVIATION 6.53 • n=30 Participants
|
35.5 years
STANDARD_DEVIATION 7.29 • n=29 Participants
|
34.2 years
STANDARD_DEVIATION 7.40 • n=148 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
13 Participants
n=29 Participants
|
12 Participants
n=28 Participants
|
13 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
12 Participants
n=29 Participants
|
64 Participants
n=148 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
16 Participants
n=29 Participants
|
16 Participants
n=28 Participants
|
17 Participants
n=30 Participants
|
17 Participants
n=30 Participants
|
17 Participants
n=29 Participants
|
84 Participants
n=148 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=28 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=29 Participants
|
3 Participants
n=148 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=2 Participants
|
28 Participants
n=29 Participants
|
27 Participants
n=28 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
28 Participants
n=29 Participants
|
145 Participants
n=148 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=148 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=29 Participants
|
2 Participants
n=148 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=148 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=148 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
8 Participants
n=29 Participants
|
7 Participants
n=28 Participants
|
13 Participants
n=30 Participants
|
16 Participants
n=30 Participants
|
10 Participants
n=29 Participants
|
54 Participants
n=148 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=2 Participants
|
21 Participants
n=29 Participants
|
20 Participants
n=28 Participants
|
17 Participants
n=30 Participants
|
14 Participants
n=30 Participants
|
17 Participants
n=29 Participants
|
91 Participants
n=148 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=28 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=148 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=148 Participants
|
|
Height (cm)
|
170.00 cm
STANDARD_DEVIATION 11.314 • n=2 Participants
|
171.41 cm
STANDARD_DEVIATION 10.442 • n=29 Participants
|
174.16 cm
STANDARD_DEVIATION 9.357 • n=28 Participants
|
173.42 cm
STANDARD_DEVIATION 8.530 • n=30 Participants
|
172.35 cm
STANDARD_DEVIATION 10.216 • n=30 Participants
|
172.32 cm
STANDARD_DEVIATION 9.781 • n=29 Participants
|
172.73 cm
STANDARD_DEVIATION 9.600 • n=148 Participants
|
|
Body Weight (kg)
|
89.55 kg
STANDARD_DEVIATION 14.213 • n=2 Participants
|
88.67 kg
STANDARD_DEVIATION 19.968 • n=29 Participants
|
92.61 kg
STANDARD_DEVIATION 21.949 • n=28 Participants
|
91.28 kg
STANDARD_DEVIATION 20.291 • n=30 Participants
|
85.82 kg
STANDARD_DEVIATION 19.027 • n=30 Participants
|
88.74 kg
STANDARD_DEVIATION 19.284 • n=29 Participants
|
89.39 kg
STANDARD_DEVIATION 19.971 • n=148 Participants
|
|
Body Mass Index (kg/m^2)
|
30.87 kg/m^2
STANDARD_DEVIATION 0.813 • n=2 Participants
|
30.05 kg/m^2
STANDARD_DEVIATION 5.528 • n=29 Participants
|
30.42 kg/m^2
STANDARD_DEVIATION 6.242 • n=28 Participants
|
30.35 kg/m^2
STANDARD_DEVIATION 6.336 • n=30 Participants
|
28.94 kg/m^2
STANDARD_DEVIATION 6.077 • n=30 Participants
|
29.80 kg/m^2
STANDARD_DEVIATION 5.687 • n=29 Participants
|
29.90 kg/m^2
STANDARD_DEVIATION 5.925 • n=148 Participants
|
|
Cigarettes per Day
|
16.50 Cigarettes per day
STANDARD_DEVIATION 4.950 • n=2 Participants
|
16.03 Cigarettes per day
STANDARD_DEVIATION 5.519 • n=29 Participants
|
16.14 Cigarettes per day
STANDARD_DEVIATION 5.848 • n=28 Participants
|
16.23 Cigarettes per day
STANDARD_DEVIATION 5.425 • n=30 Participants
|
16.57 Cigarettes per day
STANDARD_DEVIATION 6.372 • n=30 Participants
|
16.69 Cigarettes per day
STANDARD_DEVIATION 5.439 • n=29 Participants
|
16.34 Cigarettes per day
STANDARD_DEVIATION 5.660 • n=148 Participants
|
|
Years of Smoking
|
10.00 years
STANDARD_DEVIATION 0 • n=2 Participants
|
16.15 years
STANDARD_DEVIATION 9.228 • n=29 Participants
|
15.98 years
STANDARD_DEVIATION 6.784 • n=28 Participants
|
16.71 years
STANDARD_DEVIATION 10.495 • n=30 Participants
|
14.27 years
STANDARD_DEVIATION 7.924 • n=30 Participants
|
15.94 years
STANDARD_DEVIATION 8.304 • n=29 Participants
|
15.80 years
STANDARD_DEVIATION 8.579 • n=148 Participants
|
|
Fagerström test - Total score
|
—
|
4.7 points
STANDARD_DEVIATION 1.37 • n=29 Participants • The Fagerström Test for Cigarette Dependence was completed on the morning of Day 1 before any study product use. Subjects in the 'Not Assigned' group were discontinued prior to administration of the Fagerström Test and, therefore, the 'Number Analyzed' for this group is '0'.
|
4.5 points
STANDARD_DEVIATION 1.71 • n=28 Participants • The Fagerström Test for Cigarette Dependence was completed on the morning of Day 1 before any study product use. Subjects in the 'Not Assigned' group were discontinued prior to administration of the Fagerström Test and, therefore, the 'Number Analyzed' for this group is '0'.
|
5.1 points
STANDARD_DEVIATION 2.12 • n=30 Participants • The Fagerström Test for Cigarette Dependence was completed on the morning of Day 1 before any study product use. Subjects in the 'Not Assigned' group were discontinued prior to administration of the Fagerström Test and, therefore, the 'Number Analyzed' for this group is '0'.
|
4.4 points
STANDARD_DEVIATION 1.92 • n=30 Participants • The Fagerström Test for Cigarette Dependence was completed on the morning of Day 1 before any study product use. Subjects in the 'Not Assigned' group were discontinued prior to administration of the Fagerström Test and, therefore, the 'Number Analyzed' for this group is '0'.
|
5.4 points
STANDARD_DEVIATION 1.84 • n=29 Participants • The Fagerström Test for Cigarette Dependence was completed on the morning of Day 1 before any study product use. Subjects in the 'Not Assigned' group were discontinued prior to administration of the Fagerström Test and, therefore, the 'Number Analyzed' for this group is '0'.
|
4.8 points
STANDARD_DEVIATION 1.83 • n=146 Participants • The Fagerström Test for Cigarette Dependence was completed on the morning of Day 1 before any study product use. Subjects in the 'Not Assigned' group were discontinued prior to administration of the Fagerström Test and, therefore, the 'Number Analyzed' for this group is '0'.
|
PRIMARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
NNAL Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
312 ng/g
Standard Deviation 201
|
293 ng/g
Standard Deviation 213
|
392 ng/g
Standard Deviation 308
|
363 ng/g
Standard Deviation 239
|
274 ng/g
Standard Deviation 203
|
|
NNAL Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
73.2 ng/g
Standard Deviation 42.7
|
64.7 ng/g
Standard Deviation 51.0
|
71.3 ng/g
Standard Deviation 62.2
|
330 ng/g
Standard Deviation 224
|
67.8 ng/g
Standard Deviation 70.0
|
|
NNAL Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-239 ng/g
Standard Deviation 172
|
-228 ng/g
Standard Deviation 171
|
-321 ng/g
Standard Deviation 290
|
-32.8 ng/g
Standard Deviation 67.6
|
-206 ng/g
Standard Deviation 146
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted Nicotine Equivalents (NE) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during the 24 hours was converted to 24-hour urine volume using the assumed density of 1 gram (g) equals 1 milliliter (mL). The amount of biomarker was calculated as follows: NE concentration (μg/mL) = (nicotine \[ng/mL\]/162.23 \[mg/mmol\] + nicotine-gluc \[ng/mL\]/338.36 \[mg/mmol\] + cotinine \[ng/mL\]/176.22 \[mg/mmol\] + cotinine-gluc \[ng/mL\]/352.34 \[mg/mmol\] + trans-3'-hydroxycotinine \[ng/mL\]/192.22 \[mg/mmol\] + trans-3'-hydroxycotinine-gluc \[ng/mL\]/368.34 \[mg/mmol\]) × 162.23 (mg/mmol) × 1 μg/1000 ng Adjusted Nicotine equivalents (mg NE/g creatinine) = NE concentration (μg/mL) × 100 / Creatinine concentration (mg/dL) Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
NE Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
10.3 mg/g
Standard Deviation 4.83
|
10.5 mg/g
Standard Deviation 5.99
|
12.2 mg/g
Standard Deviation 7.34
|
11.6 mg/g
Standard Deviation 6.55
|
8.73 mg/g
Standard Deviation 4.42
|
|
NE Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
8.80 mg/g
Standard Deviation 6.66
|
11.8 mg/g
Standard Deviation 8.45
|
0.978 mg/g
Standard Deviation 2.35
|
10.4 mg/g
Standard Deviation 5.10
|
5.79 mg/g
Standard Deviation 5.01
|
|
NE Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-1.50 mg/g
Standard Deviation 5.81
|
1.34 mg/g
Standard Deviation 6.77
|
-11.2 mg/g
Standard Deviation 6.89
|
-1.20 mg/g
Standard Deviation 3.81
|
-2.94 mg/g
Standard Deviation 3.80
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted 2-aminonaphthalene (2-AN) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
2-AN Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
21.6 ng/g
Standard Deviation 12.0
|
19.8 ng/g
Standard Deviation 11.2
|
20.6 ng/g
Standard Deviation 11.7
|
21.7 ng/g
Standard Deviation 11.5
|
17.0 ng/g
Standard Deviation 9.93
|
|
2-AN Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
1.82 ng/g
Standard Deviation 1.36
|
1.45 ng/g
Standard Deviation 1.35
|
1.29 ng/g
Standard Deviation 1.01
|
20.2 ng/g
Standard Deviation 11.3
|
1.07 ng/g
Standard Deviation 0.728
|
|
2-AN Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-19.8 ng/g
Standard Deviation 11.8
|
-18.3 ng/g
Standard Deviation 10.9
|
-19.3 ng/g
Standard Deviation 11.7
|
-1.58 ng/g
Standard Deviation 5.10
|
-16.0 ng/g
Standard Deviation 9.77
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted 4-aminobiphenyl (4-ABP) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
4-ABP Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
13.3 ng/g
Standard Deviation 6.29
|
12.8 ng/g
Standard Deviation 6.22
|
12.8 ng/g
Standard Deviation 6.81
|
13.8 ng/g
Standard Deviation 6.74
|
10.2 ng/g
Standard Deviation 5.04
|
|
4-ABP Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
1.97 ng/g
Standard Deviation 0.749
|
1.72 ng/g
Standard Deviation 0.985
|
1.92 ng/g
Standard Deviation 1.04
|
13.2 ng/g
Standard Deviation 7.44
|
1.42 ng/g
Standard Deviation 0.450
|
|
4-ABP Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-11.3 ng/g
Standard Deviation 6.04
|
-11.1 ng/g
Standard Deviation 5.81
|
-10.9 ng/g
Standard Deviation 6.58
|
-0.589 ng/g
Standard Deviation 4.53
|
-8.75 ng/g
Standard Deviation 4.94
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted 2-hydroxyethylmercapturic acid (HEMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
HEMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
5.64 μg/g
Standard Deviation 5.29
|
5.65 μg/g
Standard Deviation 6.11
|
3.90 μg/g
Standard Deviation 3.42
|
5.19 μg/g
Standard Deviation 5.34
|
2.98 μg/g
Standard Deviation 1.69
|
|
HEMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
1.18 μg/g
Standard Deviation 0.758
|
1.55 μg/g
Standard Deviation 1.11
|
1.30 μg/g
Standard Deviation 0.762
|
4.63 μg/g
Standard Deviation 4.47
|
0.959 μg/g
Standard Deviation 0.660
|
|
HEMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-4.46 μg/g
Standard Deviation 4.63
|
-4.09 μg/g
Standard Deviation 5.50
|
-2.60 μg/g
Standard Deviation 3.22
|
-0.559 μg/g
Standard Deviation 1.80
|
-2.03 μg/g
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted cyanoethylmercapturic acid (CEMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
CEMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
154 μg/g
Standard Deviation 83.4
|
170 μg/g
Standard Deviation 72.9
|
160 μg/g
Standard Deviation 94.8
|
163 μg/g
Standard Deviation 74.1
|
133 μg/g
Standard Deviation 65.0
|
|
CEMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
18.9 μg/g
Standard Deviation 10.7
|
23.0 μg/g
Standard Deviation 13.1
|
16.0 μg/g
Standard Deviation 11.6
|
150 μg/g
Standard Deviation 72.1
|
17.4 μg/g
Standard Deviation 10.3
|
|
CEMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-135 μg/g
Standard Deviation 75.8
|
-147 μg/g
Standard Deviation 67.5
|
-144 μg/g
Standard Deviation 85.4
|
-12.4 μg/g
Standard Deviation 28.9
|
-116 μg/g
Standard Deviation 56.6
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted S-phenylmercapturic acid (SPMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
SPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
3.90 μg/g
Standard Deviation 2.41
|
3.79 μg/g
Standard Deviation 2.70
|
3.54 μg/g
Standard Deviation 3.18
|
4.41 μg/g
Standard Deviation 3.29
|
3.03 μg/g
Standard Deviation 2.24
|
|
SPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
0.183 μg/g
Standard Deviation 0.106
|
0.186 μg/g
Standard Deviation 0.140
|
0.171 μg/g
Standard Deviation 0.107
|
4.14 μg/g
Standard Deviation 3.24
|
0.149 μg/g
Standard Deviation 0.108
|
|
SPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-3.72 μg/g
Standard Deviation 2.38
|
-3.61 μg/g
Standard Deviation 2.67
|
-3.37 μg/g
Standard Deviation 3.09
|
-0.265 μg/g
Standard Deviation 0.810
|
-2.88 μg/g
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
HMPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
325 μg/g
Standard Deviation 167
|
338 μg/g
Standard Deviation 143
|
353 μg/g
Standard Deviation 198
|
371 μg/g
Standard Deviation 161
|
303 μg/g
Standard Deviation 121
|
|
HMPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
57.1 μg/g
Standard Deviation 25.0
|
48.6 μg/g
Standard Deviation 10.3
|
55.2 μg/g
Standard Deviation 12.4
|
345 μg/g
Standard Deviation 159
|
53.4 μg/g
Standard Deviation 10.4
|
|
HMPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-268 μg/g
Standard Deviation 163
|
-290 μg/g
Standard Deviation 142
|
-298 μg/g
Standard Deviation 197
|
-25.6 μg/g
Standard Deviation 75.6
|
-250 μg/g
Standard Deviation 120
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted 3-hydroxypropylmercapturic acid (3-HPMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
3-HPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
1160 μg/g
Standard Deviation 550
|
1170 μg/g
Standard Deviation 516
|
1200 μg/g
Standard Deviation 844
|
1250 μg/g
Standard Deviation 605
|
969 μg/g
Standard Deviation 414
|
|
3-HPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
259 μg/g
Standard Deviation 118
|
215 μg/g
Standard Deviation 98.7
|
281 μg/g
Standard Deviation 205
|
1170 μg/g
Standard Deviation 614
|
195 μg/g
Standard Deviation 98.9
|
|
3-HPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-897 μg/g
Standard Deviation 557
|
-957 μg/g
Standard Deviation 494
|
-923 μg/g
Standard Deviation 836
|
-82.7 μg/g
Standard Deviation 299
|
-774 μg/g
Standard Deviation 410
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted 2-hydroxypropylmercapturic acid (2-HPMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
2-HPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
11.9 μg/g
Standard Deviation 3.97
|
12.5 μg/g
Standard Deviation 7.43
|
11.9 μg/g
Standard Deviation 3.97
|
50.9 μg/g
Standard Deviation 31.8
|
9.44 μg/g
Standard Deviation 3.87
|
|
2-HPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
47.3 μg/g
Standard Deviation 28.4
|
45.4 μg/g
Standard Deviation 23.8
|
41.4 μg/g
Standard Deviation 23.6
|
52.7 μg/g
Standard Deviation 28.7
|
39.2 μg/g
Standard Deviation 19.4
|
|
2-HPMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-35.4 μg/g
Standard Deviation 26.9
|
-33.0 μg/g
Standard Deviation 26.0
|
-29.6 μg/g
Standard Deviation 22.4
|
-1.81 μg/g
Standard Deviation 13.8
|
-29.8 μg/g
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted N-acetyl-S-(2-carbamoylethyl) cysteine (AAMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
AAMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
95.6 μg/g
Standard Deviation 29.7
|
94.0 μg/g
Standard Deviation 36.4
|
94.3 μg/g
Standard Deviation 46.0
|
92.6 μg/g
Standard Deviation 30.5
|
82.6 μg/g
Standard Deviation 36.1
|
|
AAMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
39.1 μg/g
Standard Deviation 12.7
|
36.7 μg/g
Standard Deviation 13.4
|
35.9 μg/g
Standard Deviation 10.4
|
87.7 μg/g
Standard Deviation 31.8
|
29.4 μg/g
Standard Deviation 6.96
|
|
AAMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-56.5 μg/g
Standard Deviation 27.0
|
-57.3 μg/g
Standard Deviation 32.1
|
-58.3 μg/g
Standard Deviation 43.1
|
-4.90 μg/g
Standard Deviation 19.0
|
-53.1 μg/g
Standard Deviation 33.0
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-1-cysteine (GAMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
GAMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
14.3 μg/g
Standard Deviation 4.29
|
14.7 μg/g
Standard Deviation 5.23
|
14.1 μg/g
Standard Deviation 5.89
|
14.4 μg/g
Standard Deviation 6.15
|
13.1 μg/g
Standard Deviation 5.27
|
|
GAMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
7.58 μg/g
Standard Deviation 1.88
|
7.30 μg/g
Standard Deviation 2.24
|
7.26 μg/g
Standard Deviation 2.26
|
14.1 μg/g
Standard Deviation 6.48
|
5.93 μg/g
Standard Deviation 1.94
|
|
GAMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-6.77 μg/g
Standard Deviation 3.51
|
-7.35 μg/g
Standard Deviation 4.11
|
-6.79 μg/g
Standard Deviation 4.94
|
-0.256 μg/g
Standard Deviation 3.59
|
-7.20 μg/g
Standard Deviation 3.99
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted 2-hydroxybutenylmercapturic acid (2-MHBMA) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
2-MHBMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
1.60 μg/g
Standard Deviation 1.66
|
1.47 μg/g
Standard Deviation 1.37
|
1.26 μg/g
Standard Deviation 1.15
|
1.93 μg/g
Standard Deviation 1.53
|
1.24 μg/g
Standard Deviation 1.12
|
|
2-MHBMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
0.0487 μg/g
Standard Deviation 0.0466
|
0.0460 μg/g
Standard Deviation 0.0413
|
0.0729 μg/g
Standard Deviation 0.0800
|
1.74 μg/g
Standard Deviation 1.33
|
0.0359 μg/g
Standard Deviation 0.0338
|
|
2-MHBMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-1.56 μg/g
Standard Deviation 1.63
|
-1.43 μg/g
Standard Deviation 1.36
|
-1.19 μg/g
Standard Deviation 1.11
|
-0.194 μg/g
Standard Deviation 0.517
|
-1.20 μg/g
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted 2-OH-Fluorene (2-OH-Flu) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
2-OH-Flu Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
2.01 μg/g
Standard Deviation 1.08
|
2.14 μg/g
Standard Deviation 1.09
|
2.08 μg/g
Standard Deviation 1.11
|
2.24 μg/g
Standard Deviation 1.11
|
1.71 μg/g
Standard Deviation 0.890
|
|
2-OH-Flu Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
0.356 μg/g
Standard Deviation 0.141
|
0.361 μg/g
Standard Deviation 0.225
|
0.345 μg/g
Standard Deviation 0.203
|
2.08 μg/g
Standard Deviation 1.17
|
0.280 μg/g
Standard Deviation 0.144
|
|
2-OH-Flu Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-1.65 μg/g
Standard Deviation 0.995
|
-1.78 μg/g
Standard Deviation 0.916
|
-1.73 μg/g
Standard Deviation 0.931
|
-0.159 μg/g
Standard Deviation 0.401
|
-1.43 μg/g
Standard Deviation 0.777
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted 2-Naphthol (2-OH-Nap) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
2-OH-Nap Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
12.6 μg/g
Standard Deviation 5.56
|
13.8 μg/g
Standard Deviation 7.01
|
11.8 μg/g
Standard Deviation 7.60
|
11.1 μg/g
Standard Deviation 5.08
|
11.5 μg/g
Standard Deviation 8.46
|
|
2-OH-Nap Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
5.26 μg/g
Standard Deviation 3.89
|
4.80 μg/g
Standard Deviation 4.38
|
6.00 μg/g
Standard Deviation 5.56
|
10.6 μg/g
Standard Deviation 5.06
|
5.16 μg/g
Standard Deviation 6.38
|
|
2-OH-Nap Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-7.31 μg/g
Standard Deviation 5.20
|
-9.00 μg/g
Standard Deviation 5.09
|
-5.81 μg/g
Standard Deviation 5.91
|
-0.550 μg/g
Standard Deviation 2.55
|
-6.38 μg/g
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted 1-OH-Phenanthrene (1-OH-Phe) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
1-OH-Phe Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
0.172 μg/g
Standard Deviation 0.0938
|
0.171 μg/g
Standard Deviation 0.0902
|
0.191 μg/g
Standard Deviation 0.0895
|
0.218 μg/g
Standard Deviation 0.107
|
0.162 μg/g
Standard Deviation 0.0816
|
|
1-OH-Phe Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
0.0804 μg/g
Standard Deviation 0.0397
|
0.0674 μg/g
Standard Deviation 0.0380
|
0.0833 μg/g
Standard Deviation 0.0431
|
0.203 μg/g
Standard Deviation 0.108
|
0.0804 μg/g
Standard Deviation 0.0397
|
|
1-OH-Phe Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-0.0918 μg/g
Standard Deviation 0.0738
|
-0.103 μg/g
Standard Deviation 0.0685
|
-0.107 μg/g
Standard Deviation 0.0818
|
-0.0142 μg/g
Standard Deviation 0.0517
|
-0.0818 μg/g
Standard Deviation 0.0592
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted 3-hydroxybenzo\[a\]pyrene (3-OH-B\[a\]P) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
3-OH-B[a]P Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
223 pg/g
Standard Deviation 158
|
172 pg/g
Standard Deviation 139
|
166 pg/g
Standard Deviation 101
|
216 pg/g
Standard Deviation 155
|
139 pg/g
Standard Deviation 111
|
|
3-OH-B[a]P Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
82.5 pg/g
Standard Deviation 105
|
57.7 pg/g
Standard Deviation 77.6
|
84.8 pg/g
Standard Deviation 174
|
246 pg/g
Standard Deviation 215
|
30.8 pg/g
Standard Deviation 50.9
|
|
3-OH-B[a]P Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-141 pg/g
Standard Deviation 186
|
-115 pg/g
Standard Deviation 160
|
-80.8 pg/g
Standard Deviation 195
|
30.0 pg/g
Standard Deviation 192
|
-108 pg/g
Standard Deviation 109
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urine mutagenicity (Rev/24h) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. 250 mL urine sample will be concentrated to 1 mL and used for urine mutagenicity testing. Measurement results are reported as revertants/μL. Urine mutagenicity count in the 24-hour urine was calculated as: Urine mutagenicity (revertants/250 mL) = Urine mutagenicity (revertants/μL) x 1000V, where V is the volume after concentration in mL Urine mutagenicity (revertants/24 hour) = Urine mutagenicity (revertants/250 mL) x \[24h urine volume(mL) ÷ V\], where V is the volume in mL of urine sample used for the mutagenicity test
Outcome measures
| Measure |
Group 3 (NP4)
n=28 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=24 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=18 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=26 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=21 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
Urine Mutagenicity Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
9170 Revertants / 24 hours
Standard Deviation 11100
|
7580 Revertants / 24 hours
Standard Deviation 8210
|
12000 Revertants / 24 hours
Standard Deviation 12700
|
13300 Revertants / 24 hours
Standard Deviation 14000
|
8770 Revertants / 24 hours
Standard Deviation 9480
|
|
Urine Mutagenicity Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
2400 Revertants / 24 hours
Standard Deviation 3550
|
1920 Revertants / 24 hours
Standard Deviation 2440
|
3390 Revertants / 24 hours
Standard Deviation 5250
|
10800 Revertants / 24 hours
Standard Deviation 13000
|
1710 Revertants / 24 hours
Standard Deviation 3150
|
|
Urine Mutagenicity Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-6770 Revertants / 24 hours
Standard Deviation 11800
|
-5650 Revertants / 24 hours
Standard Deviation 7460
|
-8640 Revertants / 24 hours
Standard Deviation 9980
|
-2460 Revertants / 24 hours
Standard Deviation 8160
|
-6980 Revertants / 24 hours
Standard Deviation 9170
|
SECONDARY outcome
Timeframe: Samples collected over 24 hours on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of 24-hour urinary creatinine-adjusted 1-hydroxypyrene (1-OH-Pyr) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=25 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=21 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=28 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=22 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
1-OH-Pyr Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
0.145 μg/g
Standard Deviation 0.0912
|
0.174 μg/g
Standard Deviation 0.114
|
0.174 μg/g
Standard Deviation 0.115
|
0.208 μg/g
Standard Deviation 0.147
|
0.148 μg/g
Standard Deviation 0.102
|
|
1-OH-Pyr Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
0.0485 μg/g
Standard Deviation 0.0369
|
0.0506 μg/g
Standard Deviation 0.0372
|
0.0509 μg/g
Standard Deviation 0.0325
|
0.198 μg/g
Standard Deviation 0.146
|
0.0489 μg/g
Standard Deviation 0.0485
|
|
1-OH-Pyr Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-0.0969 μg/g
Standard Deviation 0.0817
|
-0.123 μg/g
Standard Deviation 0.0822
|
-0.123 μg/g
Standard Deviation 0.0935
|
-0.00991 μg/g
Standard Deviation 0.102
|
-0.0989 μg/g
Standard Deviation 0.0704
|
SECONDARY outcome
Timeframe: Samples collected at approximately 21:30 on Day -1 (baseline) and Day 7Population: Biomarker of Exposure Population (BOE): All subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. To be included in the BOE population, subjects must have baseline (Day -1) and at least one post-baseline evaluable BOE data.
Summary of blood carboxyhemoglobin (%) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. The absolute change from baseline of urine biomarker amount excreted in 24 hours and blood biomarker concentration will be calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value where Baseline = Day -1
Outcome measures
| Measure |
Group 3 (NP4)
n=28 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=24 Participants
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=18 Participants
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=26 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=21 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
Carboxyhemoglobin (COHb) Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day -1 (Baseline)
|
11.3 percent saturation
Standard Deviation 3.20
|
11.1 percent saturation
Standard Deviation 5.25
|
11.0 percent saturation
Standard Deviation 3.84
|
11.8 percent saturation
Standard Deviation 4.20
|
10.3 percent saturation
Standard Deviation 3.59
|
|
Carboxyhemoglobin (COHb) Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Day 7
|
4.60 percent saturation
Standard Deviation 1.14
|
4.60 percent saturation
Standard Deviation 0.918
|
4.22 percent saturation
Standard Deviation 1.02
|
11.3 percent saturation
Standard Deviation 4.29
|
4.99 percent saturation
Standard Deviation 1.67
|
|
Carboxyhemoglobin (COHb) Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days
Change from Baseline to Day 7
|
-6.65 percent saturation
Standard Deviation 3.28
|
-6.49 percent saturation
Standard Deviation 5.12
|
-6.77 percent saturation
Standard Deviation 3.50
|
-0.585 percent saturation
Standard Deviation 4.00
|
-5.35 percent saturation
Standard Deviation 4.01
|
SECONDARY outcome
Timeframe: Data was collected from 07:00 to 23:00 each day starting from Day 1 to Day 7/end of studyPopulation: The Product Use Population includes all subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. Only subjects in the CC group were permitted to continue smoking their own brand of cigarettes and only data for these subjects is presented in the CPD summary.
The number of cigarettes smoked per day (CPD) from 07:00 to 23:00 on Day 1 to Day 7 was collected to assess produce use behavior. Subjects in NP2, NP4, NP8 and NT groups were not allowed to use cigarettes starting at Day 1.
Outcome measures
| Measure |
Group 3 (NP4)
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=29 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
Summary of Cigarettes Smoked Per Day (CPD)
Day 1
|
—
|
—
|
—
|
16.1 cigarettes per day
Standard Deviation 5.91
|
—
|
|
Summary of Cigarettes Smoked Per Day (CPD)
Day 3
|
—
|
—
|
—
|
15.6 cigarettes per day
Standard Deviation 6.26
|
—
|
|
Summary of Cigarettes Smoked Per Day (CPD)
Day 4
|
—
|
—
|
—
|
14.8 cigarettes per day
Standard Deviation 7.25
|
—
|
|
Summary of Cigarettes Smoked Per Day (CPD)
Day 5
|
—
|
—
|
—
|
15.8 cigarettes per day
Standard Deviation 6.79
|
—
|
|
Summary of Cigarettes Smoked Per Day (CPD)
Day 6
|
—
|
—
|
—
|
15.8 cigarettes per day
Standard Deviation 7.56
|
—
|
|
Summary of Cigarettes Smoked Per Day (CPD)
Day 2
|
—
|
—
|
—
|
15.8 cigarettes per day
Standard Deviation 6.11
|
—
|
|
Summary of Cigarettes Smoked Per Day (CPD)
Day 7
|
—
|
—
|
—
|
15.9 cigarettes per day
Standard Deviation 7.18
|
—
|
SECONDARY outcome
Timeframe: Data was collected from 07:00 to 23:00 each day starting from Day 1 to Day 7/end of studyPopulation: The Product Use Population includes all subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. Only subjects in NP2, NP4 and NP8 groups used nicotine pouch products during the study and data from only these subjects are provided in the NPPD summary.
The number of nicotine pouches used per day (NPPD) from 07:00 to 23:00 on Day 1 to Day 7 was collected to assess produce use behavior. Only subjects in NP2, NP4 and NP8 groups used nicotine pouches during the study.
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=27 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=30 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
Summary of Total Number of Nicotine Pouches Used Per Day (NPPD)
Day 1
|
7.27 nicotine pouches per day
Standard Deviation 4.96
|
—
|
—
|
9.78 nicotine pouches per day
Standard Deviation 6.00
|
9.77 nicotine pouches per day
Standard Deviation 5.64
|
|
Summary of Total Number of Nicotine Pouches Used Per Day (NPPD)
Day 2
|
6.93 nicotine pouches per day
Standard Deviation 4.06
|
—
|
—
|
9.22 nicotine pouches per day
Standard Deviation 6.16
|
10.2 nicotine pouches per day
Standard Deviation 5.47
|
|
Summary of Total Number of Nicotine Pouches Used Per Day (NPPD)
Day 3
|
7.34 nicotine pouches per day
Standard Deviation 4.56
|
—
|
—
|
10.5 nicotine pouches per day
Standard Deviation 7.12
|
9.87 nicotine pouches per day
Standard Deviation 5.53
|
|
Summary of Total Number of Nicotine Pouches Used Per Day (NPPD)
Day 4
|
7.15 nicotine pouches per day
Standard Deviation 4.00
|
—
|
—
|
9.48 nicotine pouches per day
Standard Deviation 6.46
|
10.2 nicotine pouches per day
Standard Deviation 6.25
|
|
Summary of Total Number of Nicotine Pouches Used Per Day (NPPD)
Day 5
|
7.36 nicotine pouches per day
Standard Deviation 4.24
|
—
|
—
|
10.1 nicotine pouches per day
Standard Deviation 6.82
|
10.4 nicotine pouches per day
Standard Deviation 5.70
|
|
Summary of Total Number of Nicotine Pouches Used Per Day (NPPD)
Day 6
|
7.12 nicotine pouches per day
Standard Deviation 3.88
|
—
|
—
|
10.7 nicotine pouches per day
Standard Deviation 6.34
|
10.1 nicotine pouches per day
Standard Deviation 5.71
|
|
Summary of Total Number of Nicotine Pouches Used Per Day (NPPD)
Day 7
|
7.60 nicotine pouches per day
Standard Deviation 4.24
|
—
|
—
|
10.8 nicotine pouches per day
Standard Deviation 7.77
|
11.2 nicotine pouches per day
Standard Deviation 6.91
|
SECONDARY outcome
Timeframe: Data was collected from 07:00 to 23:00 each day starting from Day 1 to Day 7/end of studyPopulation: The Product Use Population includes all subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. Only subjects in NP2, NP4 and NP8 groups used nicotine pouch products during the study and data from only these subjects are provided in the NPPU summary.
The average number of nicotine pouches per use occasion (NPPU) from 07:00 to 23:00 on Day 1 to Day 7 was collected to assess produce use behavior. Only subjects in NP2, NP4 and NP8 groups used nicotine pouches during the study.
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=27 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=30 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
Summary of Average Number of Nicotine Pouches Per Use
Day 3
|
1.21 nicotine pouches per use
Standard Deviation 0.444
|
—
|
—
|
1.26 nicotine pouches per use
Standard Deviation 0.468
|
1.33 nicotine pouches per use
Standard Deviation 0.575
|
|
Summary of Average Number of Nicotine Pouches Per Use
Day 4
|
1.18 nicotine pouches per use
Standard Deviation 0.308
|
—
|
—
|
1.25 nicotine pouches per use
Standard Deviation 0.436
|
1.32 nicotine pouches per use
Standard Deviation 0.389
|
|
Summary of Average Number of Nicotine Pouches Per Use
Day 6
|
1.13 nicotine pouches per use
Standard Deviation 0.256
|
—
|
—
|
1.35 nicotine pouches per use
Standard Deviation 0.461
|
1.35 nicotine pouches per use
Standard Deviation 0.481
|
|
Summary of Average Number of Nicotine Pouches Per Use
Day 7
|
1.13 nicotine pouches per use
Standard Deviation 0.227
|
—
|
—
|
1.37 nicotine pouches per use
Standard Deviation 0.513
|
1.38 nicotine pouches per use
Standard Deviation 0.473
|
|
Summary of Average Number of Nicotine Pouches Per Use
Day 1
|
1.09 nicotine pouches per use
Standard Deviation 0.204
|
—
|
—
|
1.19 nicotine pouches per use
Standard Deviation 0.309
|
1.22 nicotine pouches per use
Standard Deviation 0.285
|
|
Summary of Average Number of Nicotine Pouches Per Use
Day 2
|
1.15 nicotine pouches per use
Standard Deviation 0.378
|
—
|
—
|
1.22 nicotine pouches per use
Standard Deviation 0.434
|
1.28 nicotine pouches per use
Standard Deviation 0.404
|
|
Summary of Average Number of Nicotine Pouches Per Use
Day 5
|
1.13 nicotine pouches per use
Standard Deviation 0.255
|
—
|
—
|
1.26 nicotine pouches per use
Standard Deviation 0.420
|
1.33 nicotine pouches per use
Standard Deviation 0.419
|
SECONDARY outcome
Timeframe: Data was collected from 07:00 to 23:00 each day starting from Day 1 to Day 7/end of studyPopulation: The Product Use Population includes all subjects from Groups 1, 2, 3, and 4 who used at least 1 of the assigned study products and all Group 5 subjects. Only subjects in NP2, NP4 and NP8 groups used nicotine pouch products during the study and data from only these subjects are provided in the summary for average duration of each nicotine pouch use.
The average duration (in minutes) of each nicotine pouch use from 07:00 to 23:00 on Day 1 to Day 7 was collected to assess produce use behavior. Only subjects in NP2, NP4 and NP8 groups used nicotine pouches during the study.
Outcome measures
| Measure |
Group 3 (NP4)
n=30 Participants
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
Group 1 (CC)
n=27 Participants
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=30 Participants
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
|---|---|---|---|---|---|
|
Summary of Average Duration of Each Nicotine Pouch Use
Day 1
|
19.1 minutes
Standard Deviation 11.4
|
—
|
—
|
23.5 minutes
Standard Deviation 13.3
|
22.4 minutes
Standard Deviation 10.3
|
|
Summary of Average Duration of Each Nicotine Pouch Use
Day 2
|
21.6 minutes
Standard Deviation 13.6
|
—
|
—
|
25.1 minutes
Standard Deviation 11.8
|
25.1 minutes
Standard Deviation 13.2
|
|
Summary of Average Duration of Each Nicotine Pouch Use
Day 3
|
23.3 minutes
Standard Deviation 13.5
|
—
|
—
|
27.6 minutes
Standard Deviation 13.4
|
25.5 minutes
Standard Deviation 14.5
|
|
Summary of Average Duration of Each Nicotine Pouch Use
Day 4
|
26.2 minutes
Standard Deviation 18.5
|
—
|
—
|
27.6 minutes
Standard Deviation 15.1
|
25.4 minutes
Standard Deviation 11.0
|
|
Summary of Average Duration of Each Nicotine Pouch Use
Day 5
|
26.8 minutes
Standard Deviation 18.8
|
—
|
—
|
27.4 minutes
Standard Deviation 14.2
|
27.3 minutes
Standard Deviation 13.2
|
|
Summary of Average Duration of Each Nicotine Pouch Use
Day 7
|
27.3 minutes
Standard Deviation 19.7
|
—
|
—
|
25.5 minutes
Standard Deviation 13.0
|
24.5 minutes
Standard Deviation 12.4
|
|
Summary of Average Duration of Each Nicotine Pouch Use
Day 6
|
28.9 minutes
Standard Deviation 20.2
|
—
|
—
|
30.1 minutes
Standard Deviation 13.8
|
26.0 minutes
Standard Deviation 13.1
|
Adverse Events
Not Assigned
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 1 (CC)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 2 (NP2)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 3 (NP4)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 4 (NP8)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 5 (NT)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Not Assigned
n=2 participants at risk
Only include subjects that enrolled in the study but dropped prior to randomization. This group includes subjects who participated in the Product Trial Period but withdrew before randomization.
|
Group 1 (CC)
n=29 participants at risk
Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.
|
Group 2 (NP2)
n=28 participants at risk
Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 1: Mint on!® 2 mg nicotine pouches
|
Group 3 (NP4)
n=30 participants at risk
Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 2: Mint on!® 4 mg nicotine pouches
|
Group 4 (NP8)
n=30 participants at risk
Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.
OTDN Product 3: Mint on!® 8 mg nicotine pouches
|
Group 5 (NT)
n=29 participants at risk
Subjects will completely stop all tobacco product usage for 7 days.
No Tobacco: subjects completely stop all tobacco product usage for 7 days
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
6.9%
2/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
13.8%
4/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
21.4%
6/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
16.7%
5/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
13.3%
4/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
13.8%
4/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
13.3%
4/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
7.1%
2/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
6.7%
2/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.6%
1/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.6%
1/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Gingival discomfort
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.6%
1/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.6%
1/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.6%
1/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
7.1%
2/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.6%
1/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.6%
1/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.6%
1/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.6%
1/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
6.9%
2/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.6%
1/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.6%
1/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Eye disorders
Visual impairment
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
General disorders
Chest pain
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
General disorders
Pain
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.3%
1/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.4%
1/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
3.6%
1/28 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/30 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
0.00%
0/29 • Adverse events were monitored from the time the subject first signs the ICF (within 28 days prior to randomization) to final discharge from the study (up to 8 days after randomization).
Subjects were observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects were also be encouraged to spontaneously report AEs occurring at any other time during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place