TABLE 5.

Adverse events during the double-blind treatment period (safety population)^a

Adverse events	Placebo N = 113	E10 mg N = 119	L10 mg N = 117	E20 mg N = 111	L20 mg N = 113	L10 + E10 mg N = 117	L10 + E20 mg N = 118	L20 + E10 mg N = 112	L20 + E20 mg N = 116	Overall N = 1036
Any TEAE
No. of events	36	34	39	43	39	30	50	35	42	348
n (%)	27 (23.9)	23 (19.3)	26 (22.2)	30 (27.0)	29 (25.7)	20 (17.1)	30 (25.4)	26 (23.2)	29 (25.7)	240 (23.2)
Treatment-related adverse eventsb
No of events	8	11	13	14	13	14	16	14	12	115
n (%)	6 (5.3)	9 (7.6)	7 (6.0)	12 (10.8)	10 (8.8)	10 (8.5)	12 (10.2)	10 (8.9)	10 (8.6)	86 (8.3)
Adverse events leading to withdrawal
No of events	2	3	2	2	2	3	1	4	2	21
n (%)	2 (1.8)	2 (1.7)	2 (1.7)	2 (1.8)	2 (1.8)	2 (1.7)	1 (0.8)	3 (2.7)	2 (1.7)	18 (1.7)

^aAdverse events with onset or increased severity anytime after the date of first dose of double-blind study drug and up to 30 days after the last dose.

^bConsidered definitely, probably or possibly related to study drug.