Table 2.

Number of adverse events and proportion of participants with at least one adverse event.

		Midazolam		Melatonin
		Events	Individuals	Events	Individuals
			N=50		N=49
All adverse events, n (%)		23	13 (26)	11	9 (18)
Intensity, n (%)	Mild	22	13 (26)	8	7 (14)
	Moderate	1	1 (2)	3	3 (6)
Relationship to study drug, n (%)	Reasonable possibility of being related	1	1 (2)	0	0 (0)
	No reasonable possibility of being related	17	11 (22)	8	6 (12)
	Not assessable	5	4 (8)	3	3 (6)
Action taken, n (%)	None	14	10 (20)	7	6 (12)
	Other	6	5 (10)	1	1 (2)
	Specific treatment	3	3 (6)	3	3 (6)
Outcome, n (%)	Recovered	20	12 (24)	11	9 (18)
	Not recovered	2	2 (4)	0	0 (0)
	Recovered with sequelae	1	1 (2)	0	0 (0)
Preferred term, n (%)	Agitation	0	0 (0)	1	1 (2)
	Anxiety	2	2 (4)	0	0 (0)
	Bradypnoea	1	1 (2)	0	0 (0)
	Emotional distress	1	1 (2)	2	2 (4)
	Epistaxis	1	1 (2)	1	1 (2)
	Flushing	1	1 (2)	0	0 (0)
	Haemorrhage	2	2 (4)	1	1 (2)
	Hypotension	2	2 (4)	0	0 (0)
	Infection	0	0 (0)	1	1 (2)
	Nausea	1	1 (2)	0	0 (0)
	Nightmare	1	1 (2)	0	0 (0)
	Pain	5	5 (10)	3	3 (6)
	Syncope	1	1 (2)	0	0 (0)
	Tachypnoea	1	1 (2)	0	0 (0)
	Vomiting	3	3 (6)	2	2 (4)
	Wound dehiscence	1	1 (2)	0	0 (0)
System organ class, n (%)	Gastrointestinal disorders	4	4 (8)	2	2 (4)
	General disorders and administration site conditions	4	4 (8)	3	3 (6)
	Infections and infestations	0	0 (0)	1	1 (2)
	Injury, poisoning, and procedural complication	1	1 (2)	0	0 (0)
	Investigations	1	1 (2)	0	0 (0)
	Nervous system disorders	1	1 (2)	0	0 (0)
	Psychiatric disorders	4	4 (8)	3	3 (6)
	Respiratory, thoracic, and mediastinal disorders	3	3 (6)	1	1 (2)
	Vascular disorders	5	5 (10)	1	1 (2)