Table 4.

Summary of safety

	Austria (n=86)	Switzerland (n=52)
Total AEs	16	15
Serious AEs	0	0
Patients with ≥1 AEs, n (%)	10 (11.6)	12 (23.1)
Diarrhoea	6 (7.0)	8 (15.4)
Drug ineffective	5 (5.8)	2 (3.9)
Abdominal distension	2 (2.3)*	0
Dizziness	0	1 (2.0)
Condition aggravated	1 (1.2)	0
Rectal tenesmus	1 (1.2)	0
Headache	0	1 (1.9)
Hot flush	0	1 (1.9)
Nausea	0	1 (1.9)
Urge incontinence	0	1 (1.9)

AEs recorded per preferred term using Medical Dictionary for Regulatory Activities V.18.0 (Austria) and V.18.1 (Switzerland).

*Two abdominal distension events reported for one patient.

AEs, adverse events.