This study will consist of 4 study periods of up to 50 months in total, consisting of:
Screening Period - A maximum screening duration of 4 weeks.
Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.
End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.
Follow-Up Period - Up to approximately 36 months, or until patient death.
A total of approximately 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.
