Trial Outcomes & Findings for Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH) (NCT NCT00449150)

Last Updated: 2018-08-03

Results Overview

The International Prostate Symptoms Score (IPSS) score of benign prostata hyperplasia (BPH) symptoms is calculated based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 points (best) to 35 points (worst)

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

667 participants

Primary outcome timeframe

Baseline and 52 weeks

Results posted on

2018-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	Cetrorelix 78+78 78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)	Cetrorelix 78+52 78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)	Placebo Placebo on Week 0, 2 26 and 28
Overall Study STARTED	219	230	218
Overall Study COMPLETED	173	177	171
Overall Study NOT COMPLETED	46	53	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Cetrorelix 78+78 78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)	Cetrorelix 78+52 78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)	Placebo Placebo on Week 0, 2 26 and 28
Overall Study Adverse Event	11	18	9
Overall Study Lack of Efficacy	1	2	2
Overall Study Other	16	13	14
Overall Study Withdrawal by Subject	17	18	21
Overall Study Protocol Violation	1	2	1

Baseline Characteristics

Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetrorelix 78+78 n=219 Participants 78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)	Cetrorelix 78+52 n=230 Participants 78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)	Placebo n=218 Participants Placebo on Week 0, 2 26 and 28	Total n=667 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	109 Participants n=5 Participants	126 Participants n=7 Participants	111 Participants n=5 Participants	346 Participants n=4 Participants
Age, Categorical >=65 years	110 Participants n=5 Participants	104 Participants n=7 Participants	107 Participants n=5 Participants	321 Participants n=4 Participants
Age, Continuous	63.86 years STANDARD_DEVIATION 8.27 • n=5 Participants	64.04 years STANDARD_DEVIATION 7.54 • n=7 Participants	64.20 years STANDARD_DEVIATION 7.76 • n=5 Participants	64.03 years STANDARD_DEVIATION 7.84 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	219 Participants n=5 Participants	230 Participants n=7 Participants	218 Participants n=5 Participants	667 Participants n=4 Participants
Region of Enrollment United States	142 participants n=5 Participants	148 participants n=7 Participants	140 participants n=5 Participants	430 participants n=4 Participants
Region of Enrollment Canada	38 participants n=5 Participants	42 participants n=7 Participants	39 participants n=5 Participants	119 participants n=4 Participants
Region of Enrollment Bulgaria	11 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	35 participants n=4 Participants
Region of Enrollment Germany	28 participants n=5 Participants	28 participants n=7 Participants	27 participants n=5 Participants	83 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 52 weeks

Population: The Intent-to-treat (ITT) population included all participants for whom at least one post-baseline efficacy assessment was available; imputation per Last Observation Carried Forward (LOCF)

Outcome measures

Outcome measures
Measure	Cetrorelix 78+78 n=211 Participants 78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)	Cetrorelix 78+52 n=226 Participants 78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)	Placebo n=213 Participants Placebo on Week 0, 2 26 and 28
International Prostate Symptoms Score (IPSS)	-4.0 Units on a scale Standard Deviation 6.61	-3.7 Units on a scale Standard Deviation 5.90	-3.8 Units on a scale Standard Deviation 6.22

SECONDARY outcome

Timeframe: Quality of life assessment in the following weeks: 4,12,26,30,38,46,52

The time course of quality of life: assessed by the following disease specific quality of life:"If you were to spend the rest of your life with the urinary conditions just the way it is now, how would you feel about that?" The rating scale is comprising a range of values from 0 to 6, with = delighted, 1 = pleased, 2 = mostly satisfied, 3 = mixed, 4 = mostly dissatisfied, 5 = unhappy, 6 = terrible.

Outcome measures

Outcome measures
Measure	Cetrorelix 78+78 n=173 Participants 78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)	Cetrorelix 78+52 n=177 Participants 78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)	Placebo n=171 Participants Placebo on Week 0, 2 26 and 28
Time Course of Quality of Life Week 38	-0.62 score on a scale Standard Deviation 1.20	-0.77 score on a scale Standard Deviation 1.38	-0.59 score on a scale Standard Deviation 1.22
Time Course of Quality of Life Week 4	-0.33 score on a scale Standard Deviation 1.16	-0.42 score on a scale Standard Deviation 1.09	-0.35 score on a scale Standard Deviation 1.00
Time Course of Quality of Life Week 12	-0.52 score on a scale Standard Deviation 1.21	-0.67 score on a scale Standard Deviation 1.25	-0.47 score on a scale Standard Deviation 1.05
Time Course of Quality of Life Week 26	-0.48 score on a scale Standard Deviation 1.18	-0.70 score on a scale Standard Deviation 1.41	-0.46 score on a scale Standard Deviation 1.07
Time Course of Quality of Life Week 30	-0.64 score on a scale Standard Deviation 1.20	-0.71 score on a scale Standard Deviation 1.40	-0.58 score on a scale Standard Deviation 1.24
Time Course of Quality of Life Week 46	-0.71 score on a scale Standard Deviation 1.28	-0.67 score on a scale Standard Deviation 1.41	-0.58 score on a scale Standard Deviation 1.20
Time Course of Quality of Life Week 52	-0.55 score on a scale Standard Deviation 1.25	-0.62 score on a scale Standard Deviation 1.39	-0.60 score on a scale Standard Deviation 1.11

Adverse Events

Cetrorelix 78+78

Serious events: 11 serious events

Other events: 177 other events

Deaths: 0 deaths

Cetrorelix 78+52

Serious events: 16 serious events

Other events: 179 other events

Deaths: 0 deaths

Placebo

Serious events: 21 serious events

Other events: 169 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Daniel Croteau, Medical Manager

AEterna Zentaris

Phone: 418-652-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Cetrorelix 78+78 n=219 participants at risk 78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)	Cetrorelix 78+52 n=230 participants at risk 78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)	Placebo n=218 participants at risk Placebo on Week 0, 2 26 and 28
Nervous system disorders IIIrd nerve paresis	0.46% 1/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Infections and infestations abdominal wall abscess	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Cardiac disorders angina pectoris	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.87% 2/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
General disorders asthenia	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Respiratory, thoracic and mediastinal disorders asthma	0.46% 1/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Cardiac disorders atrial fibrillation	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.43% 1/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Cardiac disorders atrial flutter	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) bladder cancer	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.43% 1/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Investigations blood bilirubin increased	0.46% 1/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Musculoskeletal and connective tissue disorders bursitis	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Injury, poisoning and procedural complications carbon monoxide poisoning	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.43% 1/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Infections and infestations cellulitis of legs	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Nervous system disorders cerebrovascular accident	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.92% 2/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
General disorders chest pain	0.46% 1/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Hepatobiliary disorders cholecystitis	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Hepatobiliary disorders cholecystitis acute	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Hepatobiliary disorders cholelithiasis	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.92% 2/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Cardiac disorders coronary artery disease	0.46% 1/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	1.7% 4/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Skin and subcutaneous tissue disorders decubitus ulcer	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Metabolism and nutrition disorders dehydration	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Injury, poisoning and procedural complications dislocation of joint prosthesis	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Infections and infestations diverticulitis	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) gastrointestinal carcinoma	0.46% 1/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Nervous system disorders grand mal convulsion	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.43% 1/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Vascular disorders haematoma	0.46% 1/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Metabolism and nutrition disorders hyperkalaemia	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Vascular disorders hypertensive emergency	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.43% 1/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Vascular disorders hypotension	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Infections and infestations implant site infection	0.46% 1/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Injury, poisoning and procedural complications joint dislocation	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.43% 1/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Psychiatric disorders mania	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) meningioma	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.43% 1/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Psychiatric disorders mood disorder due to a general medical condition	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Nervous system disorders muscle contractions involuntary	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Cardiac disorders myocardial infarction	0.46% 1/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Musculoskeletal and connective tissue disorders osteoarthritis	0.46% 1/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Cardiac disorders palpitations	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.43% 1/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Gastrointestinal disorders pancreatitis	0.46% 1/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Cardiac disorders pericarditis	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.43% 1/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Injury, poisoning and procedural complications post procedural haemorrhage	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.43% 1/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.

Other adverse events
Measure	Cetrorelix 78+78 n=219 participants at risk 78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)	Cetrorelix 78+52 n=230 participants at risk 78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)	Placebo n=218 participants at risk Placebo on Week 0, 2 26 and 28
Investigations ALT increased	0.46% 1/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.2% 5/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Skin and subcutaneous tissue disorders Arthralgia	5.0% 11/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	3.5% 8/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	4.6% 10/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
General disorders Asthenia	2.3% 5/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.87% 2/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.92% 2/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Musculoskeletal and connective tissue disorders Back pain	6.4% 14/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	6.1% 14/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	6.4% 14/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Respiratory, thoracic and mediastinal disorders Cough	2.7% 6/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	3.0% 7/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.3% 5/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Gastrointestinal disorders Diarrhea	5.5% 12/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	6.5% 15/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.8% 6/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Nervous system disorders Dizziness	4.1% 9/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	4.3% 10/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	5.0% 11/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Respiratory, thoracic and mediastinal disorders Erectile dysfunction	2.7% 6/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.2% 5/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	3.7% 8/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
General disorders Fatigue	2.3% 5/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.2% 5/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	4.6% 10/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.00% 0/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.8% 6/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Nervous system disorders Headache	8.2% 18/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	6.5% 15/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	7.3% 16/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Vascular disorders Hot flushes	4.1% 9/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	4.3% 10/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.8% 6/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Metabolism and nutrition disorders Hypecholesterolemia	2.3% 5/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	1.3% 3/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.92% 2/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Vascular disorders Hypertension	5.5% 12/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	3.9% 9/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	5.5% 12/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Gastrointestinal disorders Inguinal hernia	0.91% 2/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.43% 1/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.3% 5/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
General disorders Injection site pain	9.6% 21/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	7.4% 17/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	3.7% 8/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Psychiatric disorders Libido decreased	2.3% 5/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.2% 5/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.3% 5/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	7.3% 16/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	4.8% 11/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.8% 6/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Musculoskeletal and connective tissue disorders Myalgia	2.7% 6/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.2% 5/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Infections and infestations Nasopharyngitis	7.8% 17/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	10.0% 23/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	8.7% 19/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Gastrointestinal disorders Nausea	1.8% 4/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.2% 5/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	4.1% 9/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
General disorders Oedema peripheral	2.3% 5/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	1.7% 4/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	3.2% 7/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.4% 3/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.43% 1/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	3.2% 7/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Investigations PSA increased	4.6% 10/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	6.5% 15/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.3% 5/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Musculoskeletal and connective tissue disorders Pain in extremity	2.7% 6/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	1.3% 3/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.3% 5/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Reproductive system and breast disorders Prostatitis	2.3% 5/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.6% 6/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.46% 1/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Skin and subcutaneous tissue disorders Pruritus	2.7% 6/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	1.3% 3/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	1.4% 3/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Skin and subcutaneous tissue disorders Rash	5.9% 13/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.2% 5/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.8% 6/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Infections and infestations Sinusitis	1.4% 3/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	5.2% 12/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.92% 2/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Infections and infestations Upper respiratory infection	7.3% 16/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	6.5% 15/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	6.0% 13/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Renal and urinary disorders Urinary retention	2.7% 6/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	1.3% 3/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	0.92% 2/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.
Infections and infestations Urinary tract infection	2.7% 6/219 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	2.2% 5/230 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.	4.1% 9/218 • Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks. For severity grading, the following definitions will be used: * Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated * Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention * Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention A special attention will be given to assess the severity of hot flashes.