Table 2 Efficacy comparison within groups between baseline, visit 4 (4 weeks) or visit 5 (8 weeks)

 baseline

9.2 ± 2.6

8.9 ± 2.2

9.1 ± 2.8

9.6 ± 2.5

 visit 4

9.0 ± 2.8

8.0 ± 2.5

<0.001

8.0 ± 2.6

<0.001

7.4 ± 2.3

<0.001

 visit 5

9.4 ± 2.7

8.2 ± 1.8

0.009

7.5 ± 2.7

<0.001

5.7 ± 2.0

<0.001

 baseline

13.5 ± 2.9

13.0 ± 2.1

13.2 ± 2.8

13.8 ± 2.3

 visit 4

13.2 ± 3.1

11.4 ± 2.0

<0.001

11.7 ± 2.6

<0.001

11.7 ± 2.3

<0.001

 visit 5

13.3 ± 3.2

12.0 ± 2.3

0.012

11.0 ± 2.6

<0.001

10.0 ± 2.5

<0.001

 baseline

140 ± 35

143 ± 22

141 ± 36

132 ± 42

 visit 4

135 ± 37

159 ± 33

<0.001

154 ± 38

<0.001

162 ± 35

<0.001

 visit 5

136 ± 38

152 ± 24

0.025

167 ± 40

<0.001

192 ± 59

<0.001

 baseline

18/23

31/39

32/41

35/43

 visit 4

16/23

29/39

0.788

24/41

0.096

27/43

0.091

 visit 5

17/23

22/39

0.051

21/41

0.02

23/43

0.011

 baseline

1.10 ± 0.98

1.06 ± 0.96

0.97 ± 0.96

1.13 ± 1.05

 visit 4

1.20 ± 1.08

1.04 ± 0.90

0.811

0.55 ± 0.70

<0.001

0.55 ± 0.60

<0.001

 visit 5

1.18 ± 1.10

0.70 ± 0.65

<0.001

0.36 ± 0.51

<0.001

0.33 ± 0.40

<0.001

 baseline

6.8 ± 9.7

5.6 ± 8.8

7.1 ± 9.8

6.2 ± 9.1

 visit 5

7.2 ± 10.2

4.9 ± 7.9

0.412

18.3 ± 29.7

0.004

6.4 ± 9.3

0.822