Endpoints
infection, vaginal infection
INFECTION, SECONDARY, VAGINAL INFECTION
The primary endpoint was one of the failure criteria: a significant change in four key microorganisms, The secondary endpoints were as follows: (I) the proportion of participants with ≥ 1-unit-scale changes in microbial counts following device use as compared to baseline in any of the four study microorganisms; (II) proportion of participants with a Nugent score ≥ 7 following device uses; and (III) proportion of participants with vaginal infection symptoms that were bothersome or required treatment for infection.