|  | Core Study Baseline | Extension Study Baseline (6 weeks) | Extension Study Endpoint (end of additional 24 weeks of treatment) |
---|---|---|---|---|
 | Number | 141a | 139b | 95c |
PETiT TotalScore | Mean Score (SD) | 34.9 (9.3) | 39.5 (8.9) | 39.1 (9.0) |
Change from Core BL (SD) | -- | 4.5 (7.9) | 5.1 (7.2) | |
p-value | -- | <0.001 | <0.001 | |
Adherence-related Attitude Domain Score (6 items) | Mean Score (SD) | 8.6 (2.2) | 9.8 (1.9) | 9.7 (1.8) |
Change from Core BL (SD) | -- | 1.2 (2.3) | 1.3 (2.5) | |
p-value | -- | <0.001 | <0.001 | |
Psychosocial Functioning Domain Score (24 items) | Mean Score (SD) | 26.3 (8.1) | 29.7 (7.8) | 29.4 (8.0) |
Change from Core BL (SD) | -- | 3.3 (6.5) | 3.8 (5.8) | |
p-value | -- | <0.001 | <0.001 | |
Social Functioning Subdomain (4 items) | Mean Score (SD) | 3.8 (1.3) | 4.0 (1.5) | 3.9 (1.4) |
Change from Core BL (SD) | -- | 0.1 (1.4) | 0.2 (1.3) | |
p-value | -- | 0.534 | 0.361 | |
Activity Subdomain (7 items) | Mean Score (SD) | 7.8 (2.8) | 8.7 (2.8) | 8.5 (2.9) |
Change from Core BL (SD) | -- | 1.0 (2.6) | 1.1 (2.6) | |
p-value | -- | <0.001 | <0.001 | |
Cognitive Subdomain (7 items) | Mean Score (SD) | 8.2 (2.9) | 9.3 (2.7) | 9.3 (2.4) |
Change from Core BL (SD) | -- | 1.1 (2.3) | 1.3 (2.1) | |
p-value | -- | <0.001 | <0.001 | |
Dysphoria Subdomain (6 items) | Mean Score (SD) | 6.6 (2.5) | 7.7 (2.2) | 7.6 (2.6) |
Change from Core BL (SD) | -- | 1.1 (2.1) | 1.2 (2.0) | |
p-value | -- | <0.001 | <0.001 |