A clinical cure was defined by normal Amsel criteria, including: normal physiological vaginal discharge, whiff test negative for any amine "fishy" odor, saline wet mount less than 20% for clue cells, and vaginal pH is <=4.5. All four criteria had to be normal with none of the clinical failure criteria met to be considered a clinical cure. A clinical failure was defined by at least one of the following: one or more abnormal Amsel criteria, early discontinuation of study therapy due to lack of treatment effect, use of any vaginosis therapy other than study product during the study, or in the investigator's opinion, required additional treatment for vaginosis.

The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.

Solicited event assessments were captured on a memory aid starting on Day 1, the first day of therapy and continuing for 5 days. The participant recorded the presence and intensity of vulvovaginal solicited events on the memory aid. Any symptom that was present at the time that the participant was screened was considered as baseline and not reported as a solicited urogenital AE. However, if the symptom deteriorated during the reporting period, it was considered an AE. If a symptom was reported that was not present at baseline, it too was considered an AE. Any symptoms still present on Day 5 were followed by participant memory aid notations until symptom resolution. Solicited events collected include vaginal odor, vaginal pain, vaginal tenderness, vaginal itching, vaginal dryness, vaginal discharge, and vaginal inflammation. Severity of solicited events symptoms were graded as mild, moderate, or severe according to the grading table in the protocol.

The safety population includes all randomized participants who received at least one dose of study treatment. If a subject did not have solicited symptom data she was not included. In the event of an error in randomization or study product administration (i.e., incorrect product), participants were grouped by the product they actually received.

The number of participants in each treatment group with product-related SAEs was assessed. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, or a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalizations could be considered serious when, based upon appropriate medical judgment, they could jeopardize the participant and require medical or surgical intervention to prevent one of the outcomes listed. An AE was considered related if there was a reasonable possibility that the study product caused the AE, meaning that there is evidence to suggest a causal relationship between the study product and the AE.

The safety population includes all randomized participants who received at least one dose of study treatment. In the event of an error in randomization or study product administration (i.e., incorrect product), participants were grouped by the product they actually received.

Therapeutic cure was defined as both a clinical cure and a bacteriological cure. All four Amsel criteria had to be normal with none of the clinical failure criteria listed met to be considered a clinical cure, including normal physiological vaginal discharge, whiff test negative for any amine "fishy" odor, saline wet mount less than 20% for clue cells, and vaginal pH is <=4.5. A clinical failure was defined by at least one of the following: one or more abnormal Amsel criteria, early discontinuation of study therapy due to lack of treatment effect, use of any vaginosis therapy other than study product during the study, or in the investigator's opinion, required additional treatment for vaginosis. A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-3. Participants who were clinical failures, or had a Nugent score >3 were therapeutic failures.

The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.

Therapeutic cure was defined as both a clinical cure and a bacteriological cure. All four Amsel criteria had to be normal with none of the clinical failure criteria listed met to be considered a clinical cure, including normal physiological vaginal discharge, whiff test negative for any amine "fishy" odor, saline wet mount less than 20% for clue cells, and vaginal pH is <=4.5. A clinical failure was defined by at least one of the following: one or more abnormal Amsel criteria, early discontinuation of study therapy due to lack of treatment effect, use of any vaginosis therapy other than study product during the study, or in the investigator's opinion, required additional treatment for vaginosis. A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-3. Participants who were clinical failures, or had a Nugent score >3 were therapeutic failures.

The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.

A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score utilizes a 10-point scale for evaluation of vaginal flora. The Nugent score can range from 0 to 10. A score of 7 to 10 is consistent with BV while 4-6 is considered intermediate and 0-3 is negative for BV. Bacteriological cure of BV was defined as a normal Nugent score of 0-3.

The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.

A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score utilizes a 10-point scale for evaluation of vaginal flora. The Nugent score can range from 0 to 10. A score of 7 to 10 is consistent with BV while 4-6 is considered intermediate and 0-3 is negative for BV. Bacteriological cure of BV was defined as a normal Nugent score of 0-3.

The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.

A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score utilizes a 10-point scale for evaluation of vaginal flora. The Nugent score can range from 0 to 10. A score of 7 to 10 is consistent with BV while 4-6 is considered intermediate and 0-3 is negative for BV. Bacteriological cure of BV was defined as a normal Nugent score of 0-3.

The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.

A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score utilizes a 10-point scale for evaluation of vaginal flora. The Nugent score can range from 0 to 10. A score of 7 to 10 is consistent with BV while 4-6 is considered intermediate and 0-3 is negative for BV. Bacteriological cure of BV was defined as a normal Nugent score of 0-3.

The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.

A clinical cure was defined by normal Amsel criteria, including: normal physiological vaginal discharge, whiff test negative for any amine "fishy" odor, saline wet mount less than 20% for clue cells, and vaginal pH is <=4.5. All four criteria had to be normal with none of the clinical failure criteria met to be considered a clinical cure. A clinical failure was defined by at least one of the following: one or more abnormal Amsel criteria, early discontinuation of study therapy due to lack of treatment effect, use of any vaginosis therapy other than study product during the study, or in the investigator's opinion, requires additional treatment for vaginosis. Participants who did not have enough information to determine a clinical cure or clinical failure status were not evaluable for clinical cure.

The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.

The number of participants who experienced non-laboratory, non-solicited AEs following the first dose of the study product through Visit 3 (Day 22-31) was assessed. Events involving laboratory parameters that were not collected as part of the protocol were counted as non-laboratory, non-solicited adverse events.

The safety population includes all randomized participants who received at least one dose of study treatment. In the event of an error in randomization or study product administration (i.e., incorrect product), participants were grouped by the product they actually received.

The number of participants experiencing laboratory AEs following the first dose of the study product was assessed at Visit 2 (Day 8-15). A laboratory abnormality was considered an adverse event if there was a worsening of the laboratory value at Visit 2 from the baseline value and it increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined hematology parameters assessed were white blood cells, hemoglobin, platelets, and neutrophils. Protocol-defined clinical chemistry parameters assessed were creatinine, AST, ALT, total bilirubin, and glucose (random).

The safety population includes all randomized participants who received at least one dose of study treatment. In the event of an error in randomization or study product administration (i.e., incorrect product), participants were grouped by the product they actually received.