|
| AEs | SAEs | ||
| System Organ Class Preferred Term, n (%) | RLAI N = 290 | OA N = 88 | RLAI N = 290 | OA N = 88 |
| Subjects with at least one AE | 59 (20.3) | 10 (11.4) | 36 (12.4) | 4 (4.5) |
| Investigations | 4 (1.4) | 0 | 0 | 0 |
| Weight increased | 3 (1.0) | 0 | 0 | 0 |
| Metabolism and nutrition disorders | 1 (0.3) | 2 (2.3) | 0 | 0 |
| Nervous system disorders | 8 (2.8) | 1 (1.1) | 3 (1.0) | 0 |
| Extrapyramidal disorder | 2 (0.7) | 0 | 0 | 0 |
| Psychomotor hyperactivity | 2 (0.7) | 0 | 2 (0.7) | 0 |
| Psychiatric disorders | 43 (14.8) | 6 (6.8) | 26 (9.0) | 3 (3.4) |
| Depression | 5 (1.7) | 0 | 2 (0.7) | 0 |
| Insomnia | 8 (2.8) | 1 (1.1) | 0 | 0 |
| Psychotic disorder | 7 (2.4) | 1 (1.1) | 3 (1.0) | 1 (1.1) |
| Restlessness | 2 (0.7) | 0 | 1 (0.3) | 0 |
| Schizophrenia | 15 (5.2) | 1 (1.1) | 13 (4.5) | 0 |
| Suicidal ideation | 2 (0.7) | 0 | 2 (0.7) | 0 |
| Reproductive system and breast disorders | 5 (1.7) | 1 (1.1) | 0 | 0 |
| Amenorrhoea | 3 (1.0) | 1 (1.1) | 0 | 0 |
| Surgical and medical procedures | 10 (3.4) | 1 (1.1) | 10 (3.4) | 1 (1.1) |
| Hospitalization | 10 (3.4) | 1 (1.1) | 10 (3.4) | 1 (1.1) |