N | Mean | SD± | % of change vs T0 | p value | ||
---|---|---|---|---|---|---|
FIRST STAGE | ||||||
Group A placebo | ||||||
T0 | 40 | 13.93 | 8.28 | |||
T3 | 37 | 11.00 | 11.08 | 21.0 | 0.2 | |
T6 | 34 | 10.15 | 11.71 | 27.1 | 0.12 | |
T8 | 33 | 8.15 | 4.15 | 41.5 | 0.001 | |
T14FU | 32 | 6.53 | 3.21 | 53.2 | 0.0001 | |
total | 177 | 10.18 | 8.83 | |||
Group B treatment | ||||||
T0 | 40 | 14.71 | 7.65 | |||
T3 | 35 | 9.74 | 10.25 | 33.8 | 0.0218 | |
T6 | 35 | 8.00 | 10.45 | 45.6 | 0.0026 | |
T8 | 33 | 6.79 | 4.08 | 53.8 | 0.001 | |
T14FU | 33 | 5.30 | 3.82 | 63.9 | 0.0001 | |
total | 177 | 9.17 | 8.47 | |||
SECOND STAGE | ||||||
Group AA placebo/ placebo | ||||||
T0 | 22 | 6.23 | 3.13 | |||
T8 | 22 | 5.86 | 6.32 | 5.9 | 0.81 | |
T9FU | 22 | 4.64 | 8.30 | 25.5 | 0.41 | |
Group BB treatment/treatment | ||||||
T0 | 27 | 5.22 | 3.75 | |||
T8 | 27 | 5.07 | 3.05 | 2.9 | 0.87 | |
T9FU | 27 | 3.52 | 2.59 | 32.6 | 0.058 |