...
| Total | Group A | Group B | |
Randomised | N= | ||
Randomised in error
| n (% randomised) | ||
Received allocated intervention | n (% randomised) | ||
Did not receive allocated intervention
| n (% randomised) |
|
|
Declined under waiver | n (% randomised) | ||
Consented | n (% randomised) | ||
Include in intention to treat (ITT) analysis | n (% randomised) |
Assessments
Primary Outcome Assessment | Total | Group A | Group B |
Reached minimum assessment age | N= | ||
Withdrawn | n (% min age) | ||
Lost | n (% min age) | ||
Reduced participation | n (% min age) | ||
Overseas | n (% min age) | ||
| Died | n (% min age) | - | - |
Primary outcome available % of ITT analysis group | n (% min age) | ||
Other Assessment 1 (optional) | |||
Reached minimum assessment age | N= | ||
Withdrawn | n (% min age) | ||
Lost | n (% min age) | ||
Reduced participation | n (% min age) | ||
Overseas | n (% min age) | ||
Died | n (% min age) | - | - |
Specific tests (if required) | n (% min age) | ||
Other Assessment 2 (optional) | |||
Reached minimum assessment age | N= | ||
Withdrawn | n (% min age) | ||
Lost | n (% min age) | ||
Reduced participation | n (% min age) | ||
Overseas | n (% min age) | ||
Died | n (% min age) | - | - |
Specific tests (if required) | n (% min age) |