Table 2 Summary of patient disposition [18].

Enrolled

593

Randomised

284

271

555

Discontinuation from treatment phase

120 (42.3)

105 (38.7)

225 (40.5)

Lack of efficacy

33 (11.6)

20 (7.4)

53 (9.5)

Adverse event

57 (20.1)

43 (15.9)

100 (18.0)

Withdrew consent

8 (2.8)

18 (6.6)

26 (4.7)

Death

1 (0.4)

2 (0.7)

3 (0.5)

Lost to follow-up

6 (2.1)

6 (2.2)

12 (2.2)

Poor or non-compliance

10 (3.5)

10 (3.7)

20 (3.6)

Pregnancy

2 (0.7)

2 (0.7)

4 (0.7)

Non longer meets study criteria

2 (0.7)

3 (1.1)

5 (0.9)

Other

1 (0.4)

1 (0.4)

2 (0.4)

Completed treatment phase

164 (57.7)

166 (61.3)

330 (59.5)

Randomised, but did not receive study medication

2

5

7