Table 3

Adjusted change from baseline in monthly HDDs and TAC (FAS, OC, MMRM)—ESENSE 1, ESENSE 2 and SENSE (high/very high DRL at baseline and randomisation)14 15

	Number of participants at baseline		End point	Mean difference to placebo in the change from baseline	95% CI	p Value
	Nalmefene+PS	Placebo+PS	End point	Mean difference to placebo in the change from baseline	95% CI	p Value
Pooled studies (month 6) (ESENSE 1 and 2, SENSE)	460	364	HDD	−3.01 days/month	−4.36 to −1.66	<0.0001
Pooled studies (month 6) (ESENSE 1 and 2, SENSE)	460	364	TAC	−14.22 g/day	−19.96 to −8.47	<0.0001
SENSE (month 13)	141	42	HDD	−3.60 HDDs/month	−6.52 to −0.67	0.0164
SENSE (month 13)	141	42	TAC	−17.31 g/day	−30.87 to −3.76	0.0129

DRL, drinking risk level; FAS, full analysis set; HDD, heavy drinking day; MMRM, mixed model repeated measures; OC, cbserved cases; PS, psychosocial support; TAC, total alcohol consumption.