Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.

Efficacy evaluable (EE) population included all randomized participants who took at least 1 dose of study drug, who had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had a biopsy during Month 12, or had hyperplasia diagnosed before Month 12 and had no major protocol violations.

BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.

Modified Intent-to-Treat (MITT) population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had a baseline and at least 1 post baseline value. Last Observation Carried Forward (LOCF) method was used to impute missing values.

BMD measurements of the anteroposterior lumbar spine were acquired by using DXA scans, twice at Month 6 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.

MITT population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had baseline and at least 1 post baseline value. LOCF method was used to impute missing values. Here "N" signifies participants who were evaluable for this outcome measure.

BMD measurements of the total hip were acquired by using DXA scans, twice at Month 6 and 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.

MITT for osteoporosis sub-study. LOCF method was used to impute missing values. Here "n" signifies participants who were evaluable at specified time points for each arm, respectively.

Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study.

MITT population included all randomized participants who received at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here "N" signifies participants who were evaluable for this outcome measure.

Breast density was assessed by digitalized mammograms which were centrally read by a single radiologist using specifically-developed software. Breast density was assessed for subset of participants who entered the breast density sub-study

Per-Protocol (PP) population included all randomized participants who met inclusion criteria for breast density sub-study, who had a baseline and at least 1 post-baseline breast density evaluation and did not have substantial protocol violations. Here "N" signifies participants who were evaluable for this outcome measure.

Bone turnover is the removal of old bone from the body and its replacement by new bone. Bone turnover markers included serum osteocalcin, C-telopeptide, and procollagen type 1 N-propeptide (P1NP), were measured at Month 6 and Month 12 for a subset of participants who entered the osteoporosis substudy. Blood samples were collected to evaluate bone turnover markers levels.

MITT for osteoporosis substudy. Here "N" signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specified time points for each arm respectively.

Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.

MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.

Percentage of participants who reported at least 1 day of breast tenderness during each 4-week period for 1-year on therapy was calculated.

MITT population included all randomized participants who took 1 dose of study drug and had at least 20 days of data available at screening and at least 20 continuous days of data in at least one 4-week interval after baseline.

Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.

MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.

MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.

MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.

MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.

MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here "N": maximum number of participants who were evaluable for this outcome and "n": participants who were evaluable at specified time points for each arm.

Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy.

MITT population included all randomized participants who took at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here "N" signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specified time points for each arm respectively.