The severity of vaginal dryness was assessed and recorded on a questionnaire by the participants using the following 4 point scale where, 0=None (The symptom is not present), 1=Mild (The symptom is present but may be intermittent; does not interfere with participants activities or lifestyle), 2=Moderate (The symptom is present. Participant is usually aware of the symptom, but activities and lifestyle are only occasionally affected), and 3=Severe (The symptom is present. Participant is usually aware and bothered by the symptom and have modified participant's activities and/or lifestyle due to the symptom. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

Modified Intent-to-Treat Population (mITT) included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.

Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable 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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable 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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.

Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to atrophy scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.

Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to pallor scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.

Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to vaginal dryness scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.

Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to friability scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.

Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to petechiae scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.

Participant's self-assessment of symptoms of VVA (severity of vaginal dryness) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.

Participant's self-assessment of symptoms of VVA (vaginal and/or vulvar irritation/itching) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.

Participant's self-assessment of symptoms of VVA (dysuria) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.

Participant's self-assessment of symptoms of VVA (dyspareunia) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.

Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent". Percentage of participants with assessment "present" are reported. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.

Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 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 all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable 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.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable 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.

mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.