Table 4.

Treatment emergent adverse events: Zembrin versus placebo.

Category	Signs/symptoms	Minimal = 1		Mild = 2		Moderate = 3		Severe = 4
		Z	P	Z	P	Z	P	Z	P
Head	Headache	0	0		0	0	0	5	0
Eyes	Eye irritation	0	0	0	0	0	0	0	5
Eyes	Vision blurred	0	0	5	0	0	0	0	5
Ears	Poor hearing	5	5	0	0	0	0	0	0
Mouth	Hypersalivation	0	5	0	0	0	0	0	0
Mouth	Dental problems	0	0	0	0	5	5	0	0
Chest	Chest pain	0	0	5	0	0	0	0	0
Chest	Coughing	0	5	0	0	0	0	0	0
Gastrointestinal	GI discomfort	0	0	0	5	0	0	9.5	0
GI	Nausea	0	0	0	0	5	0	0	0
GI	Vomiting	0	0	0	0	5	0	0	0
GI	Constipation	0	0	0	0	0	0	5	0
GI	Flatulence	0	0	0	5	0	0	5	0
GI	Appetite increase	5	0	0	0	5	0	0	0
GI	Appetite decrease	0	5	0	10	0	5	0	0
GI	Weight gain	14	0	0	0	0	0	0	0
GI	Weight loss	5	10	0	15	0	0	0	0
GI	Thirst increase	0	0	5	0	5	0	0	0
GU	Increased frequency	0	0	0	5	0	5	0	0
GU	Genital discomfort	0	0	0	0	5	0	0	0
GU	Increased libido	0	0	0	0	0	5	0	0
Musculoskeletal	Muscle/bone/joint pain	5	0	0	5	0	10	0	5
MS	Rigidity (muscle)	0	0	0	0	5	0	0	0
Skin	Skin irritation	0	0	0	10	0	10	0	0
Skin	Hair problems	0	5	0	5	0	5	0	0
Psychiatric: PS	Tiredness/fatigue	0	0	5	0	0	0	5	0
PS	Overarousal	0	5	0	0	0	5	0	0
PS	Difficulty falling asleep	0	0	0	10	0	0	0	0
PS	Early morning awakenings	5	5	0	5	0	0	0	0
PS	Interrupted sleep	0	0	0	10	0	0	0	0
PS	Drowsiness	0	0	0	0	0	0	5	0
PS	Confusion	0	0	0	0	5	0	0	0
PS	Concentration difficulty	0	0	0	0	0	0	5	0
PS	Memory problems	0	5	0	0	5	0	0	0
PS	Depression	0	0	0	0	5	0	0	0
PS	Anxiety	0	5	0	0	5	0	0	0
PS	Irritability	0	0	0	5	0	0	0	0

NB: no life-threatening adverse events were found.

Frequency of adverse events ≥5%. Z: Zembrin treated group. P: placebo treated group.