Table 6.

Incidence of treatment-emergent abnormal value of ALT or AST

Study	ALZ2002			ALZ2004
Period	Double-blind			Double-blind			Open-label
Treatment group	Placebo	Ata 10 mg	Ata 50 mg	Placebo	Ata 10 mg	Ata 25 mg	Placebo/5 mg	Placebo/25 mg	5 mg	25 mg
AST or ALT,n	39	34	37	35	29	26	15	14	26	22
> ULN to ≤ 2× ULN,n(%)	0	5 (14.7)	8 (21.6)	2 (5.7)	1 (3.4)	7 (26.9)	4 (26.7)	2 (14.3)	3 (11.5)	7 (31.8)
> 2× ULN to ≤ 3× ULN,n(%)	0	2 (5.9)	1 (2.7)	0	2 (6.9)	1 (3.8)	0	2 (14.3)	0	0
> 3× ULN,n(%)	1 (2.6)	2 (5.9)	2 (5.4)	0	2 (6.9)	1 (3.8)	1 (6.7)	3 (21.4)	0	0

ALT alanine aminotransferase, AST aspartate aminotransferase, ULN upper limit of normal

For double-blind period 1, baseline is defined as the pre-dose baseline value from the preceding parent ALZ2002 study. For open-label period 2, baseline is defined as the last value taken on or before the day of the first dose of study drug in the open-label period