| Placebo | SPS/BIS |
Number of patients | 250 | 468 |
Gender [N (%)] Male Female |
44 (17.6) 206 (82.4) |
126 (26.9) 342 (73.1) |
Age [years] Mean (SD) |
53.1 (15.91) |
52.9 (16.75) |
Baseline number of CSBMs Mean (SD) |
1.1 (1.27) |
1.0 (1.30) |
Baseline PAC-QoL-overall score Mean (SD) |
1.95 (0.650) |
1.99 (0.700) |
Baseline PAC-QoL-worries and concerns Mean (SD) |
1.59 (0.815) |
1.66 (0.898) |
Baseline PAC-QoL-physical discomfort Mean (SD) |
2.18 (0.830) |
2.20 (0.822) |
Baseline PAC-QoL-psychosocial discomfort Mean (SD) |
1.03 (0.849) |
1.15 (0.895) |
Baseline PAC-QoL-satisfaction Mean (SD) |
2.94 (0.784) |
2.90 (0.837) |