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Clinical Adverse Events
| Adverse Event | Time | Grade | Outcome |
|---|---|---|---|
| Lower limb edema | Week 4 | Grade 1 | Resolved |
| Oral candidiasis | Week 4 | Grade 1 | Resolved (Rx fluconazole) |
| Vomiting/diarrhea | Week 4 | Grade 1 | Resolved |
| Abdominal pain/dyspepsia | Week 28 | Grade 1 | Resolved |
| Stroke (CVA) | Week 36–40 | Grade 4 | Partial improvement |
Abbreviations: CVA, cerebrovascular accident; Rx, prescription.
