Table 3.

Number and percent of adverse events by organ system

Adverse event	Placebo (n = 6)	MSF 3.6 mg (n = 6)	MSF 7.2 mg (n = 7)	MSF 10.8 mg (n = 8)
Total number of AEs n = 53	5 (9%)	10 (19%)	10 (19%)	28 (53%)
Cardiac
Palpitations	0	1 (2%)	0	0
Gastrointestinal
Nausea	0	0	1 (2%)	5 (9%)
Diarrhoea	1 (2%)	0	1 (2%)	2 (4%)
Flatulence	0	1 (2%)	1 (2%)	0
Abdominal pain	1 (2%)	0	0	0
Vomiting	0	0	1 (2%)	0
General
Asthenia	0	0	1 (2%)	0
Hyperhydrosis	0	0	0	1 (2%)
Malaise	0	0	0	1 (2%)
Infections
Nasopharyngitis	1 (2%)	3 (6%)	0	1 (2%)
Erysipelas	0	0	0	1 (2%)
Investigations
Blood amylase increased	0	1 (2%)	0	0
Lipase increased	0	1 (2%)	0	0
Musculoskeletal
Back pain	0	0	0	1 (2%)
Pain in extremities	0	0	0	1 (2%)
Nervous system
Headache	2 (4%)	2 (4%)	3 (6%)	7 (13%)
Dizziness	0	0	0	1 (2%)
Psychiatric
Abnormal dreams	0	0	0	2 (4%)
Sleep disorder	0	1 (2%)	0	1 (2%)
Agitation	0	0	0	1 (2%)
Confusion	0	0	0	1 (2%)
Depression	0	0	0	1 (2%)
Nightmares	0	0	0	1 (2%)
Respiratory
Oropharyngeal pain	0	0	1 (2%)	0
Vascular:
Secondary hypertension	0	0	1 (2%)	0