| Efficacy |
Demonstrated significant improvement |
Acknowledges results, concerns about unblinding |
| Durability of Effect |
Maintained for at least 6 months |
Concerns about interpretability |
| Safety Database |
Adequate characterization |
Limited size |
| Cardiovascular Effects |
Manageable short-term risk increases observed |
Significant concerns |
| Abuse Potential |
Low potential in therapeutic setting |
Concerns about lack of data |
| Psychotherapy Component |
Integral part of treatment |
Unclear contribution |
| Laboratory Data |
Limited data collected, no significant signals |
Claimed insufficient data collection |
| Suicidality Risk |
No increased risk observed |
Acknowledged risk potential |
| Patient Impairment |
Managed in clinical setting |
Significant concern |
| Overall Benefit-Risk Assessment |
Favorable profile |
Uncertain balance |