Statistical Analysis
All statistical analyses will be carried out on an intention-to-treat
basis. In the analysis of disease free survival,
a patient is considered to have an event if he/she
relapses after randomisation. The starting point for disease
free survival is the date of randomisation and the
terminating point is the date of first relapse or date of
death, whichever occurs first. Patients in whom there
has been no evidence of disease after treatment are censored
at the date of last follow-up. Similarly, the overall
survival time is computed from the date of randomisation
to the date when the patient is last known to be
alive.