Table 2 Adverse events attributed to treatment
| Â | Number and Severity of Adverse Events probably or definitely attributed to treatment | |||
|---|---|---|---|---|
| Â | By Participants | By Independent Rater | ||
| Â | 4Â weeks | 8Â weeks | 4Â weeks | 8Â weeks |
Distress, illness, or incidents | 4 mild 1 moderate | 0 | 4 mild 1 moderate 1 missing | 0 |
Development of new symptoms | 1 moderate | 0 | 2 mild 2 moderate | 1 mild |
Unplanned medical visits, procedures, or accidents | 0 | 0 | 0 | 0 |
Unplanned need to take medications | 1 moderate | 0 | 1 moderate 1 missing | 0 |
Other physical or mental health concerns | 4 mild | 0 | 3 mild 1 moderate | 0 |