Table 3.

Ki-67 expression, stratified by intervention group, intention-to-treat and per protocol analyses

	Intention to treat
	Ki-67 expression (%)		Crude effect size			Adjusted effect size †
	Placebo	MAG-EPA	% difference in Ki-67	(95%CI)	p-value*	% difference in Ki-67	(95%CI)	p-value
Total tumor Ki-67	n = 61	n = 60	5.5	(-16.8, 33.8)	0.66	-5.7	(-24.7, 18.1)	0.64
mean (Std)	2.85 (1.74)	3.10 (2.12)
Primary tumor Ki-67	n = 53	n = 48	6.2	(-18.6, 38.6)	0.66	-1.6	(-24.4, 28.0)	0.89
mean (Std)	2.99 (1.76)	3.15 (1.96)
Benign prostate tissue	n = 62	n = 59	-0.4	(-26.2, 34.4)	0.98	-2.5	(-28.5, 32.9)	0.70
mean (Std)	0.58 (0.55)	0.59 (0.54)
	Per protocol ‡
	Ki-67 expression (%)		Crude effect size			Adjusted effect size †
	Placebo	MAG-EPA	% difference in Ki-67	(95%CI)	p-value*	% difference in Ki-67	(95%CI)	p-value
Total tumor	n = 47	n = 46	-1.1	(-25.3, 31.0)	0.94	-14.0	(-34.0, 12.1)	0.41
mean (Std)	2.90 (1.77)	3.00 (2.08)
Primary tumor	n = 42	n = 37	-0.3	(-27.0, 36.1)	0.98	-11.5	(-34.7, 20.0)	0.60
mean (Std)	3.00 (1.74)	3.11 (2.15)
Benign prostate tissue	n = 48	n = 45	-5.0	(-32.7, 34.1)	0.77	-9.2	(36.6, 30.0)	0.45
mean (Std)	0.54 (2.55)	0.53 (0.48)

Effect size: Ki-67 was log-transformed and the percent difference of the Ki-67 expression (%) in the MAG-EPA group compared to placebo is estimated by the following: (exp(βinterv)-1) x 100. *p-value from independent samples t-test. ^† Multivariable linear regression models adjusted for ISUP grade group (2, 3 and 4 + ), PSA, and clinical stage at the biopsy before surgery. The adjusted p-value is calculated using generalized linear model (GLM) for the effect of the intervention. ^‡Included participants with a compliance of ≥80% of capsules consumed over the first 3-month period. MAG-EPA: monoacylglyceride-conjugated eicosapentaenoic acid.