Table 6.

Safety Summary (Safety Population)

	Alirocumab (n = 96)	Placebo (n = 50)
TEAEs	81 (84.4)	37 (74.0)
Treatment-emergent SAEs	12 (12.5)	7 (14.0)
TEAEs leading to discontinuation	6 (6.3)	2 (4.0)
TEAEs leading to death	0	0
Laboratory parameters	n = 95	n = 49
ALT >3× ULN	1 (1.1)	0 (0)
AST >3× ULN	1 (1.1)	1 (2.0)
CK >3× ULN	2 (2.1)	4 (8.2)

Data reported as n (%).

Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CK, creatine kinase; SAE, serious adverse event; ULN, upper limit of normal.