Table 3.
Adverse events reported by participants who completed all study visits
| Adverse Event | Study Visits | |||
|---|---|---|---|---|
| 4-week n/n (%) |
8-week n/n (%) |
12-week n/n (%) |
24-week n/n (%) |
|
| Throat irritation* | 11/34 (32,4%) | 5/32 (15,6%) | 5/30 (16,7%) | 4/27 (14,8%) |
| Mouth Irritation* | 7/34 (20,6%) | 4/32 (12,5%) | 3/30 (10,0%) | 2/27 (7,4%) |
| Sore Throat | 4/34 (11,8%) | 1/32 (3,1%) | 1/30 (3,3%) | 0/27 (0,0%) |
| Dry cough | 11/34 (32,4%) | 6/32 (18,8%) | 3/30 (10,0%) | 3/27 (11,1%) |
| Dry mouth | 3/34 (8,8%) | 1/32 (3,1%) | 1/30 (3,3%) | 1/27 (3,7%) |
| Mouth ulcers | 1/34 (2,9%) | 1/32 (3,1%) | 1/30 (3,3%) | 0/27 (0,0%) |
| Dizziness§ | 5/34 (14,7%) | 2/32 (6,3%) | 2/30 (6,7%) | 1/27 (3,7%) |
| Headache | 4/34 (11,8%) | 2/32 (6,3%) | 2/30 (6,7%) | 1/27 (3,7%) |
| Nausea | 5/34 (14,7%) | 2/32 (6,3%) | 1/30 (3,3%) | 1/27 (3,7%) |
* Throat and mouth irritation were described either as tickling, itching, or burning sensation
§ Dizziness, was also used to mean vertigo and light-headedness.