Table 4.

Adverse events reported in ≥ 2% of subjects in each group^a

Eventb	High-dose PXT3003	Low-dose PXT3003	Placebo	pc
	N = 113	N = 109	N = 101
Nausea	6 (5.3)	7 (6.4)	3 (3.0)	0.502
Diarrhea	6 (5.3)	3 (2.8)	5 (5.0)	0.620
Headache	6 (5.3)	6 (5.5)	3 (3.0)	0.639
Dry mouth	3 (2.7)	2 (1.8)	4 (4.0)	0.642
Dizziness	3 (2.7)	4 (3.7)	1 (1.0)	0.496
Muscle spasms	3 (2.7)	nil	3 (3.0)	0.223
Nasopharyngitis	3 (2.7)	4 (3.7)	5 (5.0)	0.662
Dyspepsia	2 (1.8)	1 (0.9)	2 (2.0)	0.868
Fatigue	1 (0.9)	6 (5.5)	4 (4.0)	0.132
Somnolence	1 (0.9)	5 (4.6)	1 (1.0)	0.185
Constipation	1 (0.9)	3 (2.8)	1 (1.0)	0.536
Arthralgia	1 (0.9)	3 (2.8)	2 (2.0)	0.608
Asthenia	1 (0.9)	1 (0.9)	2 (2.0)	0.693
Tinnitus	1 (0.9)	1 (0.9)	2 (2.0)	0.693
Abdominal pain	1 (0.9)	Nil	2 (2.0)	0.311
Weight increased	Nil	Nil	3 (3.0)	0.030

^aData reported as number of subjects (%)

^bCoded according to preferred terms in the Medical Dictionary for Regulatory Activities, version 18.1 or later

^cValues calculated using Fisher’s exact test. Please note that there is no correction for multiple testing, thus no control of type I error rate