Table 2. Evaluation of the toxicity of the antistenosis device.

	Phase II	Phase III	Phase III
		DUDA	No DUDA	p-value*
	N(%)	N(%)	N(%)
TOXICITY				0.52
Pain grade II	1 (4)	0	2 (1.8)
Leucorrhea	0	2 (1.8)	3 (2.7)
None	24 (96)	109 (98.2)	105 (95.5)

* p-value comparisons across treatment groups for categorical variables based on the Fisher’s exact test.