Table 3.

Adjusted estimates of absolute change in percent BD by MRI at 6 and 12 months in AI Only and Sulindac Groups (All and stratified on baseline BD ≤ or >25%).

Absolute % Change in BD (95% CI)
AI Only (n=46)
Group		N3	6- month	p-value	N4	12-month	p-value
All1		39	0.3 (−.8, +1.4)	0.561	39	−0.7 (−1.8, +0.5)	0.252
Adjust baseline BD category2	BD ≤ 25%	29	+0.2 (−1.1, +1.5)	0.809	28	−0.6 (−1.9, +0.7)	0.364
	BD > 25%	10	+0.6 (−1.7, +2.9)	0.611	11	−1.0 (−3.2, +1.3)	0.386
Sulindac plus AI (n=50)5
Group		N3	6- month	p-value	N4	12-month	p-value
All1		44	−0.3 (−1.4, +0.8)	0.563	43	−1.4 (−2.5, −0.3)	0.014
Adjust baseline BD category2	BD ≤ 25%	34	+0.1 (−1.1, 1.4)	0.840	34	−0.5 (−1.8, 0.7)	0.398
	BD >25%	9	−1.9 (−4.3, 0.5)	0.119	8	−4.7 (−7.2, −2.3)	<0.001

¹Analysis based on pooled data from both groups (n=96) and P-values were based on t-test from linear mixed model adjusted for baseline BD, time on aromatase inhibitor, BMI at each time point and study site.

²Analysis based on pooled data from both groups (n=96) and P-values were based on t-test from linear mixed model adjusted for baseline BD category, time on aromatase inhibitor, BMI at each time point and study site.

³Sample size with baseline and 6-month percent BD by MRI

⁴Sample size with baseline and 12-month percent BD by MRI

⁵Baseline BD was unavailable for 2 subjects who started sulindac (one image artifact, one image lost during IT security change on clinical instrument).