RESULTS	The primary endpoint , change from baseline in average TBR across all segments in the index vessel , was not significantly different between HD and placebo ( TBR : -0.04 [ 95 % confidence interval [ CI ] : -0.14 to +0.06 ] , p = 0.452 ) or LD and placebo ( TBR : -0.02 [ 95 % CI : -0.11 to +0.06 ] , p = 0.579 ) .\