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)