The mean change in scores on the Vitality-subscale was significantly different between the study groups at day 42 in favor of placebo ( -17.3 ( 95 % CI -30.6 , -3.9 ) , p = 0.011 ) , The mean change in scores on the VAS-F was also significantly difference between study groups at day 42 in favour of placebo ( 1.9 ( 95 % CI 0.4 , 3.5 ) , p = 0.015 ) .