Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher score indicates the most bothersome symptoms. A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.

Modified Intent-to-treat (mITT) Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint.

Vaginal pH was obtained at baseline and final visit of the study. The pH was a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.

mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint.

Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. A positive change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.

mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint.

Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.

mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint.

Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher score indicates the most bothersome symptoms. A negative change from Baseline indicates improvement.

mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint.

Self-Assessment of the symptoms of VVA, other than dyspareunia and vaginal bleeding associated with sexual activity, (vaginal and/or vulvar irritation/itching, dysuria and vaginal dryness) were evaluated by a questionnaire. Each symptom was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.

mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint.

Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent". Number of participants with assessment "present" are reported. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.

mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint.

Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to the signs of VVA: atrophy, pallor, vaginal dryness, friability, and petechiae each graded on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores are worse. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.

mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint.

Vaginal pH was obtained at baseline and final visit of the study. The pH was a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement.

mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint.

Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. A positive change from Baseline indicates improvement.

mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint.

Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. A negative change from Baseline indicates improvement.

mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint.