Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

The study periods were follows: 1. Screening: Assessments were to be completed within 28 days of randomization. 2. Treatment: The treatment period was 12 months. Discontinuation of study treatment could occur earlier than 12 months for disease recurrence, death, unacceptable toxicity or withdrawal of consent. 3. Post treatment follow-up (before recurrence): Patients were to be followed for disease recurrence every 3 months after the end of treatment until Month 24, every 6 months after Month 24 and annually after Month 60 (365 days +/- 14 days from last visit). 4. Post treatment follow-up (after recurrence): After disease recurrence patients remained on study for follow-up assessments every 3 months until Month 24, every 6 months after Month 24, and annually after Month 60 (365 days +/- 14 days from last visit).