Table 2 Outcomes assessed

Primary endpoints:

1. Percentage of women who had menstrual blood loss volume of less than 80 mL at the final month and a 50% or greater reduction in menstrual blood loss volume from baseline to the final month.

2. Mean and percentage change in MBL from baseline to last complete treatment cycle (last 28 days)

3. Percentage of bleeding days

4. Percentage of women with suppression of bleeding and amenorrhea

5. Posttreatment return to menses

6. Changes in hemoglobin concentrations

Secondary endpoints:

1. Change from baseline in the volume of the fibroid and the uterus (both assessed using ultrasound evaluation)

2. Change from baseline in Uterine Fibroid Symptom Quality of Life (UFS-QoL) questionnaire scores

3. The number of bleeding days*

4. Patient Global Impression of Change (PGIC) questionnaire for menstrual bleeding and non-bleeding uterine fibroid symptoms*

5. Change and percent change from baseline in fibroid and uterine volume

6. Change from baseline for the EuroQoL-5D (EQ-5D-5L)*

7. The Health Care Resource Utilization (HCRU) questionnaire*

8. Change from baseline for the WPAI*

1. Incidence and severity of adverse events (AEs), including AEs of special interest (e.g., hypoestrogenic AEs; osteoporosis and osteopenia; anaphylactic reaction; severe cutaneous adverse reactions and drug-induced rash; depression and suicide or self-injury)

2. Clinical laboratory assessments, including lipid panel

3. Clinically meaningful changes in ultrasound evaluation (e.g., ovarian cysts)

4. Bone mineral density.^α*

5. Relationship to the study drug (reasonable possibility or no reasonable possibility)^α*