Table 2.

Effect of randomized cocoa extract supplementation on incident T2D in intention-to-treat and per-protocol analyses

	Number of events of total
Outcome	Cocoa extract	Placebo	Model	HR1 (95% CI)	P	HR2 (95% CI)	P
Intention-to-treat analysis
Total incident T2D	405 of 9,194	396 of 9,187	1	1.03 (0.89–1.18)	0.73	1.03 (0.89–1.18)	0.73
			2	1.04 (0.91–1.20)	0.58	1.06 (0.91–1.24)	0.46
Medication-treated T2D	282 of 9,194	275 of 9,187	1	1.02 (0.87–1.21)	0.79	1.02 (0.87–1.21)	0.79
			2	1.04 (0.88–1.22)	0.68	1.06 (0.88–1.27)	0.55
Per-protocol analysis
Total incident T2D	374 of 9,194	372 of 9,187	1	1.02 (0.88–1.17)	0.84	1.02 (0.88–1.17)	0.84
			2	1.03 (0.90–1.19)	0.66	1.06 (0.91–1.24)	0.47
Medication-treated T2D	262 of 9,194	258 of 9,187	1	1.02 (0.86–1.21)	0.81	1.02 (0.86–1.21)	0.82
			2	1.04 (0.87–1.23)	0.67	1.07 (0.88–1.29)	0.51

HRs and their 95% CIs were calculated by using Cox proportional hazards regression models. We imputed missing values for covariables before modeling. For the HR1 analysis, all participants were included, while for the HR2 analysis, participants with missing data were excluded. Model 1 is adjusted for sex, age, race/ethnicity, and randomized multivitamin assignment. Model 2 is model 1 plus education, smoking, alcohol intake, physical activity, AHEI, family history of diabetes, and BMI. In the per-protocol analysis, follow-up was censored on time of noncompliance evaluated by taking <75% of the study pills.