Treatment of Bacterial Vaginosis: A Multicenter, Double-Blind, Double-Dummy, Randomised Phase III Study Comparing Secnidazole and Metronidazole

Table 1

Major deviations leading to the exclusion of patients from the per protocol population.

	Metronidazole	Secnidazole
	𝑛=287	𝑛=290
	% (𝑛)	% (𝑛)
Nonrespect of scheduled visits	4.9 (14)	3.8 (11)
Nonevaluability of primary efficacy endpoint	4.5 (13)	1.7 (5)
Concomitant antibiotic treatment	3.5 (10)	2.1 (6)
Nonrespect of compliance	2.4 (7)	1.4 (4)
of which missing data on compliance	1.4 (4)	1.4 (4)
Error in randomisation	1.4 (4)	1.4 (4)
Treatment initiated more than 3 days after randomisation	1.0 (3)	0 (0)
Nonrespect of inclusion criteria	0.3 (1)	0.7 (2)
Vaginal treatment	0 (0)	0.7 (2)
Nonrespect of exclusion criteria	0 (0)	0.3 (1)