MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The sustained responder rate was calculated as the Kaplan-Meier estimate of the cumulative probability of MBL volume < 80 mL through Week 76 using the Kaplan-Meier method.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).

MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).

MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The sustained responder rate was calculated as the Kaplan-Meier estimate of the cumulative probability of MBL volume < 80 mL through Week 104 using the Kaplan-Meier method.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).

Assessed using participant daily diary and MBL volume measured using the alkaline hematin method. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea, or No feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was >70%.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA and placebo).

MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.

mITT population: all randomized participants who had taken at least 1 dose of study treatment. The % change from Week 52 in MBL volume was only available when Week 52 MBL volume is > 0 mL and post-Week 52 MBL volumes were available. The majority of mITT participants had MBL volume of 0 mL at Week 52/Baseline (92/115 in Group A and 89/113 in Group B). Number analyzed represents proportion of mITT population with MBL volume > 0 mL at Week 52 and values at each time point.

MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.

mITT population: all randomized participants who had taken at least 1 dose of study treatment. The % change from Week 52 in MBL volume was only available when Week 52 MBL volume is > 0 mL and post-Week 52 MBL volumes were available. The majority of mITT participants had MBL volume of 0 mL at Week 52/Baseline (92/115 in Group A and 89/113 in Group B). Number analyzed represents proportion of mITT population with MBL volume > 0 mL at Week 52 and values at each time point.

Assessed using participant daily diary and MBL volume measured using the alkaline hematin method. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea or no feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was >70%.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).

MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.

Retreatment population: comprised participants in the mITT population from both treatment groups whose MBL volume reached ≥ 80 mL during the randomized treatment period and who started retreatment.

Participants who were previously amenorrhoeic were deemed to resume menses according to the following rules: MBL volume of collected feminine product was ≥5 mL; MBL volume of collected feminine product was <5 mL; however, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit; no feminine products were returned because the participant failed to collect used products per protocol; however, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit; or no feminine products were returned due to other reasons that indicated menstruation had occurred; also, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit.

mITT population who was amenorrhoeic at Week 52/Baseline: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo) and who were amenorrhoeic at Week 52/Baseline.

Assessed using participant daily diary. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea, or No feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was >70%.

mITT population who was amenorrhoeic at Week 52/Baseline: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo) and who were amenorrhoeic at Week 52/Baseline.

Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).

Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary score (Domains [number of items]: Physical Functioning [10], Role-Physical [4], Bodily Pain [2], General Health [5]), a mental component summary score (Domains [number of items]: Vitality [4], Social Functioning [2], Role-Emotional [3], and Mental Health [5]), and reported Health Transition [1]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.

The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary score (Domains [number of items]: Physical Functioning [10], Role-Physical [4], Bodily Pain [2], General Health [5]), a mental component summary score (Domains [number of items]: Vitality [4], Social Functioning [2], Role-Emotional [3], and Mental Health [5]), and reported Health Transition [1]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.

The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary (PCS) score (Domains [number of items]: Physical Functioning [10], Role-Physical [4], Bodily Pain [2], General Health [5]), a mental component summary (MCS) score (Domains [number of items]: Vitality [4], Social Functioning [2], Role-Emotional [3], and Mental Health [5]), and reported Health Transition [1]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.

The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary (PCS) score (Domains [number of items]: Physical Functioning [10], Role-Physical [4], Bodily Pain [2], General Health [5]), a mental component summary (MCS) score (Domains [number of items]: Vitality [4], Social Functioning [2], Role-Emotional [3], and Mental Health [5]), and reported Health Transition [1]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.

The PGA for function is a 1-item questionnaire designed to assess participant's impression of the impact on their function related to uterine fibroids affected their usual activities and was completed on paper. The PGA for function was evaluated using a 5-point Likert scale (1 = No limitation at all; 5 = Extreme limitation) with higher numbers representing worse results. Endpoint values represent the worsening of function (deterioration), improvement of function (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (No limitation at all) to 5 (Extreme limitation) and a 4-category improvement represents a change from 5 (Extreme limitation) to 1 (No limitation at all).

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.

The PGA for function is a 1-item questionnaire designed to assess participant's impression of the impact on their function related to uterine fibroids affected their usual activities and was completed on paper. The PGA for function was evaluated using a 5-point Likert scale (1 = No limitation at all; 5 = Extreme limitation) with higher numbers representing worse results. Endpoint values represent the worsening of function (deterioration), improvement of function (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (No limitation at all) to 5 (Extreme limitation) and a 4-category improvement represents a change from 5 (Extreme limitation) to 1 (No limitation at all).

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.

The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids and was completed on paper. The PGA for symptoms was evaluated using a 5-point Likert scale (1 = Not severe; 5 = Extremely severe) with higher numbers representing worse results. Endpoint values represent the worsening of symptoms (deterioration), improvement of symptoms (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (Not severe) to 5 (Extremely severe) and a 4-category improvement represents a change from 5 (Extremely severe) to 1 (Not severe).

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.

The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids and was completed on paper. The PGA for symptoms was evaluated using a 5-point Likert scale (1 = Not severe; 5 = Extremely severe) with higher numbers representing worse results. Endpoint values represent the worsening of symptoms (deterioration), improvement of symptoms (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (Not severe) to 5 (Extremely severe) and a 4-category improvement represents a change from 5 (Extremely severe) to 1 (Not severe).

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent work time missed due to uterine fibroids was calculated from hours missed due to uterine fibroids divided by the sum of hours missed due to uterine fibroids plus hours actually worked. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent work time missed due to uterine fibroids was calculated from hours missed due to uterine fibroids divided by the sum of hours missed due to uterine fibroids plus hours actually worked. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent impairment while working due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent impairment while working due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent overall work impairment due to uterine fibroid symptoms was calculated from the work time missed due to uterine fibroids plus the value calculated from 1 minus the work time missed value multiplied by the value for impairment while working due to uterine fibroids. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent overall work impairment due to uterine fibroid symptoms was calculated from the work time missed due to uterine fibroids plus the value calculated from 1 minus the work time missed value multiplied by the value for impairment while working due to uterine fibroids. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent activity impairment due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented activity) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent activity impairment due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages (0 to 100%), with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).

Assessed using the UFS-QOL which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer the following questions: heavy bleeding during your menstrual period (Question 1), passing blood clots during your menstrual period (Question 2), and feeling tightness or pressure in your pelvic area (Question 5). Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1, 2, and 5 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater distress and a lower score of less distress (high scores = bad).

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

Assessed using the UFS-QOL which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer the following questions: heavy bleeding during your menstrual period (Question 1), passing blood clots during your menstrual period (Question 2), and feeling tightness or pressure in your pelvic area (Question 5). Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1, 2, and 5 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater distress and a lower score of less distress (high scores = bad).

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

Assessed using the UFS-QOL, which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1 through 8 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater symptom severity and a lower score of lower symptom severity (negative score = improvement).

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

Assessed using the UFS-QOL, which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1 through 8 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater symptom severity and a lower score of lower symptom severity (negative score = improvement).

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.

Assessed using the UFS-QOL which, is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. Items are scored on a 5-point scale, ranging from "none of the time" to "all of the time." The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Questions 9 through 37 were used to calculate the total scores and the following subscales: concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function. All raw scores are transformed to normalized scores with a range of possible values from 0 to 100. A positive score indicates improvement.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.

Assessed using the UFS-QOL which, is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. Items are scored on a 5-point scale, ranging from "none of the time" to "all of the time." The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Questions 9 through 37 were used to calculate the total scores and the following subscales: concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function. All raw scores are transformed to normalized scores with a range of possible values from 0 to 100. A positive score indicates improvement.

mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.

Blood samples were collected from participants for estradiol measurements and were analyzed using a standard clinical methodology. The change from Week 52/Baseline in estradiol concentration at Week 56 was presented in this outcome.

Safety population: all randomized participants who received at least 1 dose of study treatment. Overall number of participants analyzed represents proportion of overall group with values at that time point.

Assessed by percentage of participants with AEs and serious AEs (SAEs). An AE was defined as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or a congenital anomaly/birth defect. Events of heavy menstrual bleeding were only reported if the event met criteria as an SAE. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.

Assessed by dual-energy X-ray absorptiometry scan at the lumbar spine (L1-L4), total hip [presented separately], and femoral neck (same leg within each participant) [presented separately] at each designated timepoints. The least squares means and their 95% CI were based on analysis of covariance model with treatment, stratification factors, race as fixed factors, and age at Week 52/Baseline, Week 52/Baseline BMD value, and body mass index at Week 52/Baseline as covariates.

Safety population: all randomized participants who received at least 1 dose of study treatment. Note: 1 patient was randomized to placebo and inadvertently dispensed open-label study drug; the patient took 1 dose and was considered part of Group A in the Safety population only and is represented in the Overall Number of Participants Analyzed. Number analyzed by location/group represents proportion of the Safety population with values for that measure at that time point.

Assessed by dual-energy X-ray absorptiometry scan at the lumbar spine (L1-L4) [presented separately], total hip, and femoral neck (same leg within each participant) at each designated timepoints. The least squares means and their 95% CI were based on analysis of covariance model with treatment, stratification factors, race as fixed factors, and age at Week 52/Baseline, Week 52/Baseline BMD value, and body mass index at Week 52/Baseline as covariates.

Safety population: all randomized participants who received at least 1 dose of study treatment. Note: 1 patient was randomized to placebo and inadvertently dispensed open-label study drug; the patient took 1 dose and was considered part of Group A in the Safety population only and is represented in the Overall Number of Participants Analyzed. Number analyzed by location/group represents proportion of the Safety population with values for that measure at that time point.