Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: an 8-week open-label extension study

Table 1 Subject disposition

Screened					392
Double-blind Treatment Period	DFN-11		Placebo		Total
Randomized	131		137		268
Completed	111		123		234
Discontinued	20		14		34
Open-label Treatment Period (All active DFN-11)	Treatment Received During DB, Prior to OL Period				Overall
	DFN-11		Placebo
Enrolled	111^a		123^a		234
Completed	96^a		109^a		205
Discontinued	15^a		14^a		29
Reasons for discontinuation	Discont. During DB	Discont. During OLE^a	Discont. During DB	Discont. During OLE^a	OLE Total	DB + OLE
Adverse event	2	3	0	2	5	7
Lost to follow-up	3	8	3	1	9	15
Protocol violation	1	1	1	3	4	6
Withdrew consent	3	2	2	5	7	12
Investigator decision	1	0	1	2	2	4
Other	10	1	7	1	2	19
Total discontinued	20	15	14	14	29	63

ISSN: 1129-2377