Table 2 Primary outcome and secondary outcomes in per-protocol population during the follow-up of the study

 V1

0

6.1 ± 1.3

5.4–6.6

6.0 ± 1.5

5.2–6.8

0.9855

ns

 V2

1

3.2 ± 2.1

2.2–4.2

2.5 ± 1.7

1.6–3.3

0.3675

ns

 V3

5

2.3 ± 1.8

1.4–3.2

2.5 ± 1.5

1.7–3.2

0.6525

ns

 V4

15

1.4 ± 1.2

0.8–2.0

3.6 ± 2.1

2.5–4.7

0.001

***

 V5

30

1.6 ± 1.9

0.7–2.6

4.0 ± 1.6

3.2–4.8

< 0.0001

****

 V6

58

2.9 ± 1.5

2.2–3.6

5.1 ± 1.9

4.1–6.0

0.0008

***

 V1

0

36.3 ± 10.7

31.2–41.4

28.9 ± 8.3

24.6–33.1

0.0570

ns

 V2

1

61.2 ± 14.4

54.6–67.4

65.9 ± 13.4

59.0–72.8

0.1925

ns

 V3

5

68.8 ± 14.8

61.7–75.9

64.1 ± 17.4

55.2–73.0

0.3747

ns

 V4

15

78.7 ± 11.4

73.3–84.2

58.2 ± 15.9

50.1–66.4

0.0004

***

 V5

30

77.5 ± 14.2

70.6–84.3

56.3 ± 17.4

47.4–65.3

0.0008

***

 V6

58

62.0 ± 15.6

54.5–69.6

39.8 ± 16.3

32.8–46.8

0.0002

***

 V1

0

57.8 ± 7.1

54.4–62.2

53.2 ± 8.4

48.8–57.5

0.0998

ns

 V2

1

81.3 ± 12.6

75.2–87.4

83.2 ± 9.9

78.1–88.4

0.7598

ns

 V3

5

85.7 ± 10.5

80.6–90.7

80.9 ± 11.0

75.3–86.6

0.1925

ns

 V4

15

88.8 ± 9.4

84.2–93.3

73.2 ± 13.4

66.2–80.0

0.0013

**

 V5

30

86.8 ± 11.9

81.1–92.5

71.2 ± 13.7

64.2–78.3

0.0008

***

 V6

58

77.3 ± 12

71.6–83.1

60.3 ± 13.7

53.3–67.3

0.0004

***