Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail (NCT NCT02267356)
NCT ID: NCT02267356
Last Updated: 2020-11-04
Results Overview
Complete cure was defined as 0% nail involvement and an Investigator Global Assessment (IGA) score of 0. Mycological cure was defined as negative potassium hydroxide (KOH) and negative dermatophyte culture. Investigator Global Assessment (IGA) scoring: 0: 0% nail involvement 1. \>0% to ≤10% nail involvement 2. \>10% to \<25% nail involvement 3. ≥25% to ≤50% nail involvement 4. \>50% to ≤75% nail involvement 5. \>75% nail involvement
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
259 participants
Primary outcome timeframe
48 weeks
Results posted on
2020-11-04
Participant Flow
Participant milestones
| Measure |
Low Dose 12-week
2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
|
Low Dose 24-week
2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
|
High Dose 12-week
4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
|
High Dose 24-week
4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks
|
Placebo
4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
|
|---|---|---|---|---|---|
|
Initial Study
STARTED
|
53
|
53
|
52
|
54
|
47
|
|
Initial Study
COMPLETED
|
47
|
48
|
42
|
43
|
42
|
|
Initial Study
NOT COMPLETED
|
6
|
5
|
10
|
11
|
5
|
|
Study Extension
STARTED
|
33
|
37
|
30
|
32
|
26
|
|
Study Extension
COMPLETED
|
32
|
37
|
29
|
30
|
26
|
|
Study Extension
NOT COMPLETED
|
1
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail
Baseline characteristics by cohort
| Measure |
Low Dose 12-week
n=53 Participants
2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
|
Low Dose 24-week
n=53 Participants
2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
|
High Dose 12-week
n=52 Participants
4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
|
High Dose 24-week
n=54 Participants
4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks
|
Placebo
n=47 Participants
4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 9.41 • n=93 Participants
|
50.4 years
STANDARD_DEVIATION 10.28 • n=4 Participants
|
49.4 years
STANDARD_DEVIATION 12.79 • n=27 Participants
|
49.0 years
STANDARD_DEVIATION 10.45 • n=483 Participants
|
52.7 years
STANDARD_DEVIATION 11.69 • n=36 Participants
|
50.0 years
STANDARD_DEVIATION 10.96 • n=10 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
51 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
38 Participants
n=36 Participants
|
208 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Initial 60-week study data. Study extension data not applicable.
Complete cure was defined as 0% nail involvement and an Investigator Global Assessment (IGA) score of 0. Mycological cure was defined as negative potassium hydroxide (KOH) and negative dermatophyte culture. Investigator Global Assessment (IGA) scoring: 0: 0% nail involvement 1. \>0% to ≤10% nail involvement 2. \>10% to \<25% nail involvement 3. ≥25% to ≤50% nail involvement 4. \>50% to ≤75% nail involvement 5. \>75% nail involvement
Outcome measures
| Measure |
Low Dose 12-week
n=53 Participants
2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
|
Low Dose 24-week
n=53 Participants
2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
|
High Dose 12-week
n=52 Participants
4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
|
High Dose 24-week
n=54 Participants
4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks
|
Placebo
n=47 Participants
4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
|
|---|---|---|---|---|---|
|
The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48
|
17 Participants
|
19 Participants
|
22 Participants
|
18 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 9 monthsOutcome measures
| Measure |
Low Dose 12-week
n=33 Participants
2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
|
Low Dose 24-week
n=37 Participants
2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
|
High Dose 12-week
n=30 Participants
4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
|
High Dose 24-week
n=32 Participants
4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks
|
Placebo
n=26 Participants
4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
|
|---|---|---|---|---|---|
|
Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities
|
8 Participants
|
5 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
Adverse Events
Low Dose 12-week
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Low Dose 24-week
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
High Dose 12-week
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
High Dose 24-week
Serious events: 5 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose 12-week
n=53 participants at risk
Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 10 weeks, followed by placebo for 12 weeks
|
Low Dose 24-week
n=53 participants at risk
Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 22 weeks
|
High Dose 12-week
n=52 participants at risk
Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 10 weeks, followed by placebo for 12 weeks
|
High Dose 24-week
n=54 participants at risk
Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 22 weeks
|
Placebo
n=47 participants at risk
Matching placebo tablets for 24 weeks
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemorrhagic anemia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
General disorders
Chest pain
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
General disorders
Pyrexia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Psychiatric disorders
Depression
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Reproductive system and breast disorders
Postmenopausal hemmorage
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Vascular disorders
Artery dissection
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
Other adverse events
| Measure |
Low Dose 12-week
n=53 participants at risk
Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 10 weeks, followed by placebo for 12 weeks
|
Low Dose 24-week
n=53 participants at risk
Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 22 weeks
|
High Dose 12-week
n=52 participants at risk
Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 10 weeks, followed by placebo for 12 weeks
|
High Dose 24-week
n=54 participants at risk
Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 22 weeks
|
Placebo
n=47 participants at risk
Matching placebo tablets for 24 weeks
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.8%
2/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
2/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
7th nerve paralysis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Dizziness
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
4.3%
2/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
5.6%
3/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Headache
|
3.8%
2/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.8%
2/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Hyperesthesia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Migraine
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Nervous system disorders
Tremor
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Psychiatric disorders
Depression
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
4.3%
2/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.8%
2/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.8%
2/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea syndrome
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.7%
2/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.8%
2/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.8%
2/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
5.7%
3/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.8%
2/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
9.6%
5/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
5.6%
3/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Scar
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Vascular disorders
Hot flush
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Vascular disorders
Hypertension
|
3.8%
2/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
5.6%
3/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
4.3%
2/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Congenital, familial and genetic disorders
Congenital aural fistula
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.8%
2/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Eye disorders
Dry eye
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Eye disorders
Meibomian gland dysfunction
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Eye disorders
Vision blurred
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
2/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.8%
2/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.8%
2/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.7%
2/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
4.3%
2/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.8%
2/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.8%
2/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
7.7%
4/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
7.4%
4/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Esophagitis
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Toothache
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
3/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
General disorders
Asthenia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
General disorders
Chest discomfort
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
General disorders
Chest pain
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
General disorders
Fatigue
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
General disorders
Edema peripheral
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
General disorders
Pain
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
General disorders
Pyrexia
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Immune system disorders
Hypersensitivity
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Immune system disorders
Seasonal allergy
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Cystitis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Diverticulitis
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Influenza
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Nasopharyngitis
|
9.4%
5/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
7.7%
4/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.7%
2/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
4.3%
2/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Otitis media
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Paronychia
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
7.7%
4/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
7.4%
4/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.8%
2/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
4/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
5.7%
3/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
9.6%
5/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
9.3%
5/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
8.5%
4/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Infections and infestations
Viral infection
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Eye injury
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Injury
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.8%
2/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.7%
2/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.8%
2/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.8%
2/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.8%
2/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Tooth avulsion
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Injury, poisoning and procedural complications
Traumatic hematoma
|
5.7%
3/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Investigations
Blood pressure increased
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Investigations
Electrocardiogram change
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Investigations
Weight decreased
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
3.8%
2/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
2/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
5.8%
3/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
2.1%
1/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/53
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
1.9%
1/52
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/54
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
0.00%
0/47
Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.
|
Additional Information
Sr Vice President, Clinical Development
Mycovia Pharmaceuticals
Phone: (919) 467-8539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Neither Institution nor Principal Investigator shall publish the results of the Trial without the prior written consent of Sponsor, which it may withhold in its sole discretion.
- Publication restrictions are in place
Restriction type: OTHER