| Number of participants | |||||
---|---|---|---|---|---|---|
Study 1 | Study 2 | Study 3 | ||||
Enrolment | ||||||
 Total screened | 266 | 229 | 197 | |||
 Randomised | 242 | 222 | 192 | |||
 Not randomised | 24 | 7 | 5 | |||
  Not eligible | 14 | 7 | 1 | |||
  Withdrew consent | 9 | 0 | 4 | |||
  Lost to follow-up | 1 | 0 | 0 | |||
Allocation | Test | Control | Test | Control | Test | Control |
Randomised/received | 121 | 121 | 111 | 111 | 97 | 95 |
Follow-up | ||||||
 Completed study | 119 | 121 | 111 | 111 | 97 | 95 |
  Withdrew consent | 1 | 0 | 0 | 0 | 0 | 0 |
  Lost to follow-up | 1 | 0 | 0 | 0 | 0 | 0 |
Analysis | ||||||
Safety/ITT/PP populations | 121 | 121 | 111 | 111 | 97 | 95 |