Table 2.

Two-Year Disease-Free Survival.

	Events (1)	Relative Risk (Unadjusted) RR (95% CI)	P Value	Relative Risk (Adjusted) (2) RR (95% CI)	P Value
	Melatonin N (%)	Placebo N (%)
Intention to Treat	80 (22.5)	85 (24.1)	1.07 (0.81 – 1.41)	0.64	1.01 (0.83 – 1.22)	0.94
Per Protocol	58 (23.3)	51 (20.4)	1.24 (1.08 – 1.42)	0.001	1.12 (0.96 – 1.32)	0.14

Melatonin (N = 356); Placebo (N = 353).

(1) An event is defined as a recurrence or mortality (i.e., one or the other) within 2 years of surgery.

(2) Adjusted for adjuvant chemotherapy, adjuvant radiation, and baseline smoking status.