Table 3.

Assessment of no-harm: mean change from baseline in MRI measurements of plaque burden after 24 months and PET/CT measurement of inflammation after 6 months

	24-month, mean (SE)		Least squares mean of absolute change from baseline (SE)		Absolute change from baseline relative to placebo (90% CI)	No-harm boundary*	p value†
	Placebo	Dalcetrapib	Placebo	Dalcetrapib
Carotid MRI‡
Total vessel area at 24 months§ (mm2)	67·53 (2·34)	61·44 (1·87)	5·72 (1·45)	1·71 (1·43)	−4·01 (−7·23 to −0·80)	2 mm2	0·04
Wall area at 24 months§ (mm2)	32·28 (1·43)	28·57 (0·86)	2·69 (1·05)	0·49 (1·04)	-2·20 (−4·54 to 0·13)	3 mm2	0·12
Wall thickness at 24 months¶ (mm)	1·27(0·04)	1·19 (0·03)	0·05 (0·03)	0·02 (0·03)	−0·03 (−0·11 to 0·04)	0·02 mm	0·45
Normalised wall index at 24 months§ (%)	47·0 (1·0)	47·0 (1·0)	−0·40 (0·80)	0·30 (0·80)	0·60 (−1·20 to 2·50)	4·00%	0·57
Index vessel PET/CT∥
Most diseased segment mean of maximum TBR at 6 months**	2·54(0·08)	2·56(0·10)	-0·26 (0·08)	-0·19 (0·08)	0·07 (−0·11 to 0·25)	0·27	0·51

SE=standard error. TBR=target-to-background ratio. Comparisons between timepoints were restricted to patients with data available at both timepoints.

^*No-harm assessed by comparison of the upper limit of the 90% CI for placebo-corrected change from baseline with the no-harm boundary, based on effects noted in previous studies and assuming linearity over time (full details in text).

^†p values (2-sided) are presented for the difference between groups.

^‡Total number of patients with MRI vessel parameter measurements was 56 for placebo and 58 for dalcetrapib.

^§For total vessel area, wall area, and normalised wall index, n=39 for placebo and n=44 for dalcetrapib.

^¶For wall thickness, n=38 for placebo and n=44 for dalcetrapib.

^∥Total number of patients with target-to-background ratio measurements was 56 for placebo and 56 for dalcetrapib.

^**For most diseased segment mean of maximum TBR, n=52 for placebo and n=54 for dalcetrapib.