48 3.3.1 Inclusion criteria .............................................................................................. 48 3.3.2 Exclusion criteria ............................................................................................ 48 3.3.3 Removal of patients from the trial, therapy or assessment .............................. 49 3.3.3.1 Patient withdrawal ........................................................................................... 49 3.3.3.2 Trial discontinuation ....................................................................................... 50 3.3.3.3 Procedures for discontinuation ........................................................................ 50 3.4 Time schedule ............................................................................................................ 51 4.