Trial Outcomes & Findings for AI-09 In Subjects With Glabellar Lines, GL-101 (NCT NCT05565950)
NCT ID: NCT05565950
Last Updated: 2026-08-31
Results Overview
Investigator and Subject Assessment (R=I+S-C≤1), percentage of responders achieving a score of 0 (Absent) or 1 (Mild) on the Glabellar Line Severity scale where severity is scored between 0-3 (0=absent; 3=severe).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
96 participants
Primary outcome timeframe
4 Weeks
Results posted on
2026-08-31
Participant Flow
Participants were excluded if they were unable to substantially lessen glabellar lines by physically spreading them apart, had excessive weakness or atrophy in the target muscle(s), eyelid ptosis, presence or history of "dry eye", history of periocular surgery, brow lift or related procedures, or deep dermal scarring, or had used any other botulinum toxin drug product anywhere in the body in the last 6 months.
Participant milestones
| Measure |
Vehicle
Vehicle, intramuscular injection, administered once at baseline
Vehicle: Vehicle Formulation
|
AI-09 Dose 1
Dose 1 (lowest dose), AI-09 botulinum toxin, Type A, intramuscular injection, administered once at baseline
|
AI-09 Dose 2
Dose 2 (twice the concentration of Dose 1), AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 3
Dose 3 (twice the concentration of Dose 2), AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 4
Dose 4 (twice the concentration of Dose 3), AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 5
Dose 5 (twice the concentration of Dose 4), AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 6
Dose 6 (twice the concentration of Dose 5), AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 7
Dose 7, the highest dose (twice the concentration of Dose 6), AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
2
|
4
|
6
|
8
|
12
|
17
|
16
|
|
Overall Study
Included in the Per Protocol Population
|
28
|
0
|
3
|
6
|
8
|
12
|
16
|
15
|
|
Overall Study
COMPLETED
|
26
|
1
|
2
|
6
|
5
|
11
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
2
|
0
|
3
|
1
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AI-09 In Subjects With Glabellar Lines, GL-101
Baseline characteristics by cohort
| Measure |
Vehicle
n=31 Participants
Vehicle, intramuscular injection, administered once at baseline
Vehicle: Vehicle Formulation
|
AI-09 Dose 1
n=2 Participants
Dose 1, AI-09 botulinum toxin, Type A, intramuscular injection, administered once at baseline
|
AI-09 Dose 2
n=4 Participants
Dose 2, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 3
n=6 Participants
Dose 3, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 4
n=8 Participants
Dose 4, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 5
n=12 Participants
Dose 5, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 6
n=17 Participants
Dose 6, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 7
n=16 Participants
Dose 7, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.9 Years
n=14 Participants
|
53.0 Years
n=36 Participants
|
45.2 Years
n=324 Participants
|
49.0 Years
n=49 Participants
|
43.8 Years
n=573 Participants
|
53.5 Years
n=9 Participants
|
48.7 Years
n=8 Participants
|
52.0 Years
n=7 Participants
|
49.9 Years
n=18 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=14 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=324 Participants
|
5 Participants
n=49 Participants
|
7 Participants
n=573 Participants
|
11 Participants
n=9 Participants
|
17 Participants
n=8 Participants
|
14 Participants
n=7 Participants
|
88 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=573 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=573 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=573 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=573 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
1 Participants
n=49 Participants
|
0 Participants
n=573 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=14 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=324 Participants
|
5 Participants
n=49 Participants
|
8 Participants
n=573 Participants
|
12 Participants
n=9 Participants
|
9 Participants
n=8 Participants
|
14 Participants
n=7 Participants
|
81 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=573 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=573 Participants
|
0 Participants
n=9 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 4 WeeksPopulation: Per Protocol
Investigator and Subject Assessment (R=I+S-C≤1), percentage of responders achieving a score of 0 (Absent) or 1 (Mild) on the Glabellar Line Severity scale where severity is scored between 0-3 (0=absent; 3=severe).
Outcome measures
| Measure |
AI-09 Dose 4
n=8 Participants
Dose 4, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 5
n=12 Participants
Dose 5, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 6
n=16 Participants
Dose 6, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 7
n=15 Participants
Dose 7, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
Vehicle
n=28 Participants
Vehicle, intramuscular injection, administered once at baseline
Vehicle: Vehicle Formulation
|
AI-09 Dose 1
Dose 1, AI-09 botulinum toxin, Type A, intramuscular injection, administered once at baseline
|
AI-09 Dose 2
n=3 Participants
Dose 2, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 3
n=6 Participants
Dose 3, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Responders by Dose Group at the Week 4 Visit; R=I+S-C≤1
|
0 Participants
|
8 Participants
|
10 Participants
|
11 Participants
|
1 Participants
|
—
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: Per Protocol population
% of responders with improvement in the Investigator and Subject's Self Assessment on Contraction, IGA-C, using the Glabellar Line Severity scale (GLS), where severity is scored between 0-3 (0=absent; 3=severe). A "responder" is defined as a change by at least two ordinals assessments.
Outcome measures
| Measure |
AI-09 Dose 4
n=8 Participants
Dose 4, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 5
n=12 Participants
Dose 5, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 6
n=16 Participants
Dose 6, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 7
n=15 Participants
Dose 7, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
Vehicle
n=28 Participants
Vehicle, intramuscular injection, administered once at baseline
Vehicle: Vehicle Formulation
|
AI-09 Dose 1
Dose 1, AI-09 botulinum toxin, Type A, intramuscular injection, administered once at baseline
|
AI-09 Dose 2
n=3 Participants
Dose 2, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 3
n=6 Participants
Dose 3, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
|---|---|---|---|---|---|---|---|---|
|
% of Responders at Week 4 With Improvement From Baseline On-contraction by at Least 2 Points by Investigator and Subject's Self Assessment (I+S-C CfB≥2), on the Glabellar Line Severity Scale Where Severity is Scored Between 0-3 (0=Absent; 3=Severe).
|
0 Participants
|
7 Participants
|
9 Participants
|
7 Participants
|
15 Participants
|
—
|
0 Participants
|
1 Participants
|
Adverse Events
Vehicle
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AI-09 Dose 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AI-09 Dose 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AI-09 Dose 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
AI-09 Dose 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AI-09 Dose 5
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AI-09 Dose 6
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AI-09 Dose 7
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vehicle
n=31 participants at risk
Vehicle, intramuscular injection, administered once at baseline
|
AI-09 Dose 1
n=2 participants at risk
Dose 1, AI-09 botulinum toxin, Type A, intramuscular injection, administered once at baseline
|
AI-09 Dose 2
n=4 participants at risk
Dose 2, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 3
n=6 participants at risk
Dose 3, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 4
n=8 participants at risk
Dose 4, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 5
n=12 participants at risk
Dose 5, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 6
n=17 participants at risk
Dose 6, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 7
n=16 participants at risk
Dose 7, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Cerebrovascular accident
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
6.2%
1/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
Other adverse events
| Measure |
Vehicle
n=31 participants at risk
Vehicle, intramuscular injection, administered once at baseline
|
AI-09 Dose 1
n=2 participants at risk
Dose 1, AI-09 botulinum toxin, Type A, intramuscular injection, administered once at baseline
|
AI-09 Dose 2
n=4 participants at risk
Dose 2, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 3
n=6 participants at risk
Dose 3, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 4
n=8 participants at risk
Dose 4, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 5
n=12 participants at risk
Dose 5, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 6
n=17 participants at risk
Dose 6, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
AI-09 Dose 7
n=16 participants at risk
Dose 7, AI-09 botulinum toxin, Type A, intra-muscular injection, administered once at baseline
|
|---|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
3.2%
1/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Infections and infestations
COVID-19
|
6.5%
2/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
25.0%
1/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
8.3%
1/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
6.2%
1/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Reproductive system and breast disorders
Premenstrual Headache
|
3.2%
1/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.2%
1/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
12.5%
1/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Gastrointestinal disorders
Gastroenteritis Viral
|
3.2%
1/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
50.0%
1/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
50.0%
1/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
50.0%
2/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
12.5%
1/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
16.7%
2/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
6.2%
1/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
16.7%
1/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Gastrointestinal disorders
Oropharyngeal Pain
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
16.7%
1/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
12.5%
1/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
16.7%
1/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Infections and infestations
Influenza
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
12.5%
1/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
8.3%
1/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Nervous system disorders
Migraine
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
12.5%
1/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
8.3%
1/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
5.9%
1/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
8.3%
1/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Eye disorders
Swelling of the eyelid
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
8.3%
1/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Ear and labyrinth disorders
Ear infection
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
8.3%
1/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
8.3%
1/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
5.9%
1/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Gastrointestinal disorders
Tonsillar ulcer
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
5.9%
1/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
5.9%
1/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Vascular disorders
Hypotension
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
5.9%
1/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/31 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/2 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/4 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/6 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/8 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/12 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
0.00%
0/17 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
6.2%
1/16 • From screening at Week 0 until final visit at Week 26
Safety was assessed during the study by collection of study events, review of concomitant treatments and laboratory data. Clinical adverse event reporting was conducted at each visit.
|
Additional Information
Sr. VP R & D and Regulatory Operations
Eirion Therapeutics
Phone: 2158721131
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee During the Study and for a period of five (5) years after completion of the Study, Site and Investigator will not, without Sponsor's prior written consent, publish, disseminate or otherwise disclose, deliver or make available to any third party, other than Study Personnel or Sponsor's designees for the purpose of conducting the Study, or any IRB, any Confidential Information.
- Publication restrictions are in place
Restriction type: OTHER