TABLE 2.

Intention-to-treat and per-protocol analyses of the comparative risk of (i) fall or major osteoporotic fracture and (ii) all-cause mortality for new users of zopiclone vs. trazodone within 180 days

	Trazodone (n=1,403)	Zopiclone (n=1,599)
Injurious fall or major osteoporotic fracture
Events per 100 person-yrs (95% CI)
Intention-to-treat	17.5 (17.3,17.7)	17.7 (17.5,17.8)
Per protocol	9.83 (9.70,9.95)	7.48 (7.37,7.59)
Hazard ratio (95% CI)
Crude	1 (ref)	0.89 (0.70, 1.13)
Intention-to-treat	1 (ref)	1.15 (0.90, 1.48)
Per protocol	1 (ref)	0.85 (0.60, 1.21)
All-cause Mortality
Events per 100 person-yrs (95% CI)
Intention-to-treat	38.8 (38.6,39.1)	38.4 (38.2,38.7)
Per protocol	13.4 (13.3,13.6)	15.5 (15.3,15.6)
Hazard ratio (95% CI)
Crude	1 (ref)	0.96 (0.82,1.13)
Intention-to-treat	1 (ref)	0.96 (0.79, 1.16)
Per protocol	1 (ref)	0.90 (0.66, 1.23)

CI = confidence interval; HR = hazard ratio; n = number; ref = reference.