Table 2.

 Analysis of Primary Outcome

	BV Treatment Failure,a % (n/N)
	Intent-to-Treat Population (n = 214)	Per-Protocol Populationb (n = 133)
Arm
Metronidazole	81 (87/107)	72 (50/69)
Placebo	80 (86/107)	75 (48/64)
Two-sided P valuec	>.999	.844

In the intent-to-treat population, 51 who did not attend the last visit were treated as failures; this includes 31 without any BV testing and 20 with negative BV tests at follow-up visits 1 and/or 2.

Abbreviation: BV, bacterial vaginosis.

^aParticipants with recurrence/persistence through the third follow-up visit (day 112–119) were added to the cumulative failures for the study. Participants who did not return for their test-of-cure visit were also considered treatment failures.

^bIncludes women whose partners completed treatment and excludes pre-existing protocol violations of entry criteria.

^cFisher’s exact test.