Table 3.

Most clinically relevant treatment-related adverse events (safety population)

	Placebo group (n = 9)	Liarozole 75 mg group (n = 27)	Liarozole 150 mg group (n = 28)	Liarozole, combined groups (n = 55)
Laboratory abnormalities, n
Increased plasma creatine phosphokinase	0	1	2	3
Increased alanine aminotransferase	0	0	1	1
Increased plasma lipids	0	0	2	2
Increased blood cell count	1	0	0	0
Physical examination abnormalities, n	0	1a	3b	4
Vital signs abnormalities, n	0	1c	1c	2
Ophthalmological abnormalities, n	0	0	1d	1
Electrocardiogram abnormalities, n	0	0	2e	2
Mucocutaneous symptoms, n	1f	6g	4h	10

^aMild shoulder pain, mild arthralgia and mild pain in extremity;

^bmoderate rash (one patient), mild hypertension (one patient), moderate herpes simplex and moderate lymphadenopathy (one patient);

^chypertension (mild in 150-mg group, moderate in 75-mg group);

^dmoderate worsening of Schirmer's tear test and tearfilm break-up time;

^emoderate ventricular extrasystoles (one patient), mild abnormal electrocardiogram (not further specified) that was already reported at screening (one patient);

^fmild alopecia;

^gmild epistaxis (three patients), mild cheilitis (two patients), moderate cheilitis (one patient), moderate alopecia (one patient);

^hmoderate epistaxis (one patient), mild alopecia (one patient), mild alopecia and mild cheilitis (two patients).