2.4.1. Nugent Score
The primary endpoint of MED-01 was a change in the Nugent score between baseline and 12 weeks after randomization. To reduce the multicenter error, all collected samples from the subjects at screening visits and 6 and 12 weeks were sent to an external centralized analysis institution (Korea Clinical Laboratory, Seoul, Korea) within 48 h. A trained professional prepared vaginal swabs and smears and stained the smears. Scoring was performed by a qualified microbiologist to increase the reliability of the test results. Gram staining of the vaginal smears was used to determine the Nugent score (