Patient enrolment | Reason for discontinuation | Sham TTT | TTT |
Enrolled | 50 | 50 | |
Randomised | 50 | 50 | |
Excluded from study | |||
Erroneous diagnosis on review | 2 | ||
Discontinued treatment before first TTT | 4 | 2 | |
Patient's decision | 1 | 1 | |
Adverse event before first TTT* | 3 | 1 | |
Received randomised treatment | 44 | 48 | |
Discontinued treatment before month 24 | 4 | 11 | |
Adverse event† | 1 | 4 | |
Patient's decision | 2 | ||
Unsatisfactory therapeutic effort | 3 | 4 | |
Protocol deviation | 1 | ||
Remained on treatment at month 24 | 40 | 38 |