Table 2 Primary and secondary outcomes. Change within and difference between the groups from baseline to follow-ups

 Baseline

71

40.1 (6.3)

n/a

46

41.6 (6.8)

n/a

n/a

n/a

 3-month follow-up

70

39.4 (7.3)

−0.6 [− 1.9, 0.6]

45

41.0 (6.9)

−0.8 [− 2.4, 0.8]

0.2 [− 1.8, 2.1]

0.877

 6-month follow-up

62

39.1 (7.4)

−1.0 [− 2.1, 0.2]

40

41.2(6.2)

− 1.4 [− 2.8, 0.0]

0.4 [− 1.4, 2.2]

0.650

 12-month follow-up

54

40.1 (6.4)

−0.6 [− 1.7, 0.6]

36

40.2 (7.3)

− 1.0 [− 2.5, 0.4]

0.5 [− 1.4, 2.3]

0.618

 Baseline

67

3167 (2410)

n/a

45

2654 (1817)

n/a

n/a

n/a

 3-month follow-up

64

3471 (2395)

647 [146, 1148]

41

2864 (1908.28)

−95 [− 698, 509]

741 [−44, 1526]

0.064

 6-month follow-up

61

3319 (2527)

365 [−191, 921]

43

2918 (1809)

139 [− 530, 808]

226 [− 653, 1104]

0.611

 12-month follow-up

57

2774 (2114)

−3 [− 511, 505]

37

2636 (1714)

− 136 [− 763, 491]

133 [− 679, 945]

0.745

 Baseline

62

2.4 (14.1)

n/a

44

0.0 (0.0)

n/a

n/a

n/a

 3-month follow-up

56

1.2 (6.9)

−0.6 [−2.3, 1.0]

40

0.3 (2.2)

−1.1 [− 2.9, 0.7]

0.5 [− 2.0, 2.9]

0.711

 6-month follow-up

49

3.1 (12.1)

1.1 [−1.8, 4.0]

32

0.7 (2.9)

−0.9 [−4.4, 2.7]

2.0 [−2.6, 6.6]

0.390

 12-month follow-up

52

3.8 (13.7)

2.1 [−1.5, 5.6]

33

1.7 (8.7)

0.2 [−4.3, 4.6]

1.9 [−3.8, 7.6]

0.508

 Baseline

66

19.7 (25.7)

n/a

45

18.7 (24.9)

n/a

n/a

n/a

 3-month follow-up

68

11.8 (20.2)

−8.1 [−13.1, −3.1]

43

19.8 (28.6)

3.1 [−3.1, 9.4]

−11.3 [− 19.3, − 3.2]

0.006

 6-month follow-up

55

16.5 (24.6)

−2.8 [− 8.8, 3.2]

41

13.9 (22.9)

−3.2 [− 10.1, 3.7)

0.4 [− 8.7, 9.5]

0.934

 12-month follow-up

53

14.2 (20.8)

−0.5 [−5.8, 4.9]

37

18.9 (25.4)

4.2 [−2.3, 10.7]

−4.6 [−13.1, 3.8]

0.277

 Baseline

61

18.6 (24.9)

n/a

44

18.0 (24.7)

n/a

n/a

n/a

 3-month follow-up

56

15.0 (22.5)

−6.1 [−12.1, −0.2]

40

18.9 (26.5)

3.2 [−3.5, 9.9]

−9.3 [−18.3, − 0.4]

0.042

 6-month follow-up

49

19.5 (26.9)

0.4 [−5.8, 6.7]

32

12.6 (19.9)

0.1 [−7.6, 7.8]

0.3 [−9.7, 10.3]

0.947

 12-month follow-up

52

16.3 (24.8)

2.1 [−2.9, 7.2]

32

18.8 (23.6)

5.0 [−1.3, 11.3]

−2.9 [− 10.9, 5.2]

0.481

 Baseline

74

30.9 (24.7)

n/a

50

28.8 (23.4)

n/a

n/a

n/a

 3-month follow-up

71

26.6 (27.0)

−4.4 [−9.5, 0.7]

46

26.1 (25.9)

−3.7 [−10.0, 2.7]

−0.7 [−8.8, 7.5]

0.868

 6-month follow-up

61

35.6 (31.4)

5.9 [−0.7, 12.4]

43

25.1 (25.4)

−3.0 [−10.8, 4.8]

8.8 [−1.4, 19.0]

0.089

 12-month follow-up

60

29.0 (29.4)

0.7 [−4.9, 6.3]

38

22.9 (21.0)

−3.3 [−10.3, 3.8]

4.0 [−5.0, 13.0]

0.382