Table 3.

Adverse events during the 6-month follow-up period

	AZD8601 3 mg (n = 7)	Placebo (n = 4)
Any adverse event, n (%)	5 (71.4)	4 (100)
Related to study druga	1 (14.3)	1 (25)
Fatal adverse event, n (%)	0 (0)	0 (0)
Serious adverse event, n (%)b	2 (28.6)	1 (25)
Related to study drug	0 (0)	0 (0)
Anemiac	0 (0)	1 (25)
Cataractd	1 (14.3)	0 (0)
Chest paind	1 (14.3)	0 (0)
Dizzinessd	0 (0)	1 (25)
Dyslipidemiad	0 (0)	1 (25)
Dyspneac	0 (0)	1 (25)
Embolic cerebral infarctionc	1 (14.3)	0 (0)
Feeling coldd	1 (14.3)	0 (0)
Gynecomastiad	1 (14.3)	0 (0)
Incision site impaired healingc	1 (14.3)	0 (0)
Incision site inflammationc	1 (14.3)	0 (0)
Insomniad	0 (0)	1 (25)
Left ventricular dysfunctionc	1 (14.3)	0 (0)
Liver function test increasedd	0 (0)	1 (25)
Myalgiad	0 (0)	1 (25)
Non-cardiac chest painc	0 (0)	1 (25)
Pain in extremityc	1 (14.3)	0 (0)
Skin necrosise	0 (0)	1 (25)
Syncoped	1 (14.3)	0 (0)
Tachycardiac	1 (14.3)	0 (0)
Vascular graft occlusione	1 (14.3)	0 (0)
Vertigod	1 (14.3)	0 (0)
Wound infectionc	0 (0)	1 (25)

^aGynecomastia in one patient in the AZD8601 group and increased liver function test in one patient in the placebo group.

^bEmbolic cerebral infarction and vascular graft occlusion in one patient in the AZD8601 group; incision site impaired healing and incision site inflammation in one patient in the AZD8601 group; and skin necrosis in one patient in the placebo group.

^cModerate maximum intensity.

^dMild maximum intensity.

^eSevere maximum intensity.