Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease (NCT NCT05655520)

Last Updated: 2025-12-17

Results Overview

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

153 participants

Primary outcome timeframe

Baseline, Last value on study (up to 24 months)

Results posted on

2025-12-17

Participant Flow

Participation of a study partner was optional in this study and was only to support completion of study activities and answer questions about the participant's condition. Only participants with Huntington's Disease enrolled in this study represented enrollment number. Data presented in all the sections of the results represents data exclusively collected and analyzed for participants with Huntington's Disease enrolled in this study.

A total of 165 participants were screened, of which, 153 participants were enrolled and received study treatment in either Cohort 1 (Direct rollover) or Cohort 2 (Gap rollover). The study was terminated early by the Sponsor and hence, no participants were enrolled in Cohort 3 (De novo) and therefore no data was collected and reported. No additional milestone.

Participant milestones

Participant milestones
Measure	Cohort 1 (Direct Rollover) Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 milligrams (mg), orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Overall Study STARTED	72	81
Overall Study COMPLETED	2	4
Overall Study NOT COMPLETED	70	77

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 (Direct Rollover) Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 milligrams (mg), orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Overall Study Adverse Event	2	3
Overall Study Physician Decision	2	0
Overall Study Non-Compliance with Study Drug	0	2
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	4	4
Overall Study Study Terminated by Sponsor	61	68

Baseline Characteristics

A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 (Direct Rollover) n=72 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=81 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Total n=153 Participants Total of all reporting groups
Age, Continuous	51.9 years STANDARD_DEVIATION 8.02 • n=6 Participants	51.2 years STANDARD_DEVIATION 9.21 • n=5 Participants	51.6 years STANDARD_DEVIATION 8.65 • n=5 Participants
Sex: Female, Male Female	34 Participants n=6 Participants	38 Participants n=5 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=6 Participants	43 Participants n=5 Participants	81 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=6 Participants	0 Participants n=5 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	0 Participants n=6 Participants	2 Participants n=5 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or other Pacific Islander	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	68 Participants n=6 Participants	77 Participants n=5 Participants	145 Participants n=5 Participants
Race/Ethnicity, Customized Race · Multiple	0 Participants n=6 Participants	1 Participants n=5 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	3 Participants n=6 Participants	1 Participants n=5 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanice or Latino	8 Participants n=6 Participants	5 Participants n=5 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	64 Participants n=6 Participants	76 Participants n=5 Participants	140 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Population: The Safety Set included all participants who were administered IP during the study.

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=72 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=81 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)	46 Participants	46 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Population: The Safety Set included all participants who were administered IP during the study.

A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Severity was assessed as: Mild: symptoms barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptoms. Moderate: symptoms of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptoms may be needed. Severe: symptoms cause severe discomfort; symptoms cause incapacitation or significant impact on participant's daily life; severity may cause cessation of treatment with IP; treatment for symptoms may be given and/or participant hospitalized. Participant with multiple instances of events is counted only once using maximum intensity.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=72 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=81 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Number of Participants With at Least One TEAE by Severity Mild	21 Participants	24 Participants
Number of Participants With at Least One TEAE by Severity Moderate	22 Participants	18 Participants
Number of Participants With at Least One TEAE by Severity Severe	3 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Population: The Safety Set included all participants who were administered IP during the study.

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE with onset or after the start of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=72 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=81 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Number of Participants Who Withdrew From Study Due to TEAEs	2 Participants	3 Participants

PRIMARY outcome

Timeframe: Baseline; Last Value on Study (up to 24 months)

Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for vital sign parameters for this outcome measure.

Vital signs parameter for blood pressure included systolic blood pressure (supine), systolic blood pressure (standing 1 minute), systolic blood pressure (standing 3 minutes), diastolic blood pressure (supine), diastolic blood pressure (standing 1 minute), and diastolic blood pressure (standing 3 minutes). Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=71 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=80 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Vital Signs: Blood Pressure CFB: Diastolic Blood Pressure (Supine)	1.2 mmHg Standard Deviation 8.10	-1.1 mmHg Standard Deviation 9.02
Change From Baseline in Vital Signs: Blood Pressure Change From Baseline (CFB): Systolic Blood Pressure (Supine)	0.2 mmHg Standard Deviation 11.49	0.4 mmHg Standard Deviation 14.61
Change From Baseline in Vital Signs: Blood Pressure CFB: Systolic Blood Pressure (Standing 1 minute)	-1.8 mmHg Standard Deviation 17.63	1.0 mmHg Standard Deviation 14.72
Change From Baseline in Vital Signs: Blood Pressure CFB: Systolic Blood Pressure (Standing 3 minute)	-2.0 mmHg Standard Deviation 13.85	-0.3 mmHg Standard Deviation 13.94
Change From Baseline in Vital Signs: Blood Pressure CFB: Diastolic Blood Pressure (Standing 1 minute)	1.4 mmHg Standard Deviation 11.41	-0.7 mmHg Standard Deviation 10.27
Change From Baseline in Vital Signs: Blood Pressure CFB: Diastolic Blood Pressure (Standing 3 minute)	0.5 mmHg Standard Deviation 10.33	-1.3 mmHg Standard Deviation 11.02

PRIMARY outcome

Timeframe: Baseline, Last value on study (up to 24 months)

Vital signs for heart rate included heart rate (supine), heart rate (standing 1 minute), and heart rate (standing 3 minute). Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=71 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=80 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Vital Signs: Heart Rate CFB: Heart Rate Supine	2.2 beats/min Standard Deviation 9.66	2.7 beats/min Standard Deviation 9.91
Change From Baseline in Vital Signs: Heart Rate CFB: Heart Rate Standing 1 Minute	1.8 beats/min Standard Deviation 13.13	2.2 beats/min Standard Deviation 11.45
Change From Baseline in Vital Signs: Heart Rate CFB: Heart Rate Standing 3 Minute	1.7 beats/min Standard Deviation 12.65	2.1 beats/min Standard Deviation 14.00

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=71 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=80 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Vital Signs: Respiratory Rate	0.0 breaths/min Standard Deviation 2.64	-0.1 breaths/min Standard Deviation 2.76

PRIMARY outcome

Timeframe: Baseline, Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=71 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=80 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Vital Signs: Temperature	0.9 degree Celsius Standard Deviation 7.519	0.058 degree Celsius Standard Deviation 0.3650

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=68 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=78 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets CFB: Monocytes	0.01 cells*10^9/L Standard Deviation 0.134	0.03 cells*10^9/L Standard Deviation 0.115
Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets CFB: Neutrophils	-0.20 cells*10^9/L Standard Deviation 1.561	0.06 cells*10^9/L Standard Deviation 1.230
Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets CFB: Platelets	6.6 cells*10^9/L Standard Deviation 37.38	4.2 cells*10^9/L Standard Deviation 30.31
Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets CFB: Eosinophils	0.00 cells*10^9/L Standard Deviation 0.091	0.02 cells*10^9/L Standard Deviation 0.101
Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets CFB: Erythrocytes	0.004 cells*10^9/L Standard Deviation 0.2369	0.015 cells*10^9/L Standard Deviation 0.2312
Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets CFB: Leukocytes	-0.21 cells*10^9/L Standard Deviation 1.609	0.07 cells*10^9/L Standard Deviation 1.328
Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets CFB: Lymphocytes	-0.03 cells*10^9/L Standard Deviation 0.317	-0.04 cells*10^9/L Standard Deviation 0.362
Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets CFB: Basophils	0.00 cells*10^9/L Standard Deviation 0.039	0.01 cells*10^9/L Standard Deviation 0.052

PRIMARY outcome

Timeframe: Baseline, Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=68 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=78 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes CFB: Basophils/Leukocytes	0.02 percent Standard Deviation 0.313	-0.02 percent Standard Deviation 0.240
Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes CFB: Eosinophils/Leukocytes	0.04 percent Standard Deviation 1.259	0.32 percent Standard Deviation 1.268
Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes CFB: Lymphocytes/Leukocytes	-0.11 percent Standard Deviation 6.984	-0.66 percent Standard Deviation 6.023
Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes CFB: Monocytes/Leukocytes	0.32 percent Standard Deviation 2.427	0.57 percent Standard Deviation 1.547
Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes CFB: Neutrophils/Leukocytes	-0.25 percent Standard Deviation 8.792	-0.20 percent Standard Deviation 7.208

PRIMARY outcome

Timeframe: Baseline, Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=68 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=78 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Hematology- Erythrocytes (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin CFB: Ery. Mean Corpuscular HGB Concentration	-2.7 grams per liter (g/L) Standard Deviation 11.85	-4.9 grams per liter (g/L) Standard Deviation 9.24
Change From Baseline in Clinical Laboratory Parameters: Hematology- Erythrocytes (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin CFB: Hemoglobin	-0.0 grams per liter (g/L) Standard Deviation 6.69	-0.3 grams per liter (g/L) Standard Deviation 8.15

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=68 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=78 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Hemoglobin	-0.02 picograms (pg) Standard Deviation 0.740	-0.17 picograms (pg) Standard Deviation 0.953

PRIMARY outcome

Timeframe: Baseline, Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=68 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=78 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Volume	0.61 femtoliters (fL) Standard Deviation 3.091	0.85 femtoliters (fL) Standard Deviation 2.884

PRIMARY outcome

Timeframe: Baseline, Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=68 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=78 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Hematology - Hematocrit	0.0033 liters per liter (L/L) Standard Deviation 0.0256	0.0055 liters per liter (L/L) Standard Deviation 0.0271

PRIMARY outcome

Timeframe: Baseline, Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=71 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=79 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase CFB: Alanine Aminotransferase	-1.2 units per liter (U/L) Standard Deviation 10.80	0.6 units per liter (U/L) Standard Deviation 11.42
Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase CFB: Alkaline Phosphatase	1.7 units per liter (U/L) Standard Deviation 13.17	2.2 units per liter (U/L) Standard Deviation 13.04
Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase CFB: Aspartate Aminotransferase	-1.7 units per liter (U/L) Standard Deviation 5.56	1.0 units per liter (U/L) Standard Deviation 9.79
Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase CFB: Creatinine Kinase	-28.6 units per liter (U/L) Standard Deviation 135.53	-0.8 units per liter (U/L) Standard Deviation 83.46
Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase CFB: Gamma Glutamyl Transferase	3.1 units per liter (U/L) Standard Deviation 14.47	4.0 units per liter (U/L) Standard Deviation 31.75
Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase CFB: Lactate Dehydrogenase	-9.6 units per liter (U/L) Standard Deviation 19.89	4.2 units per liter (U/L) Standard Deviation 25.26

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

HDL= high-density lipoprotein LDL= low-density lipoprotein Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=71 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=79 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen CFB: Bicarbonate	-0.1 millimole per liter (mmol/L) Standard Deviation 2.68	0.0 millimole per liter (mmol/L) Standard Deviation 2.51
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen CFB: Calcium	-0.005 millimole per liter (mmol/L) Standard Deviation 0.0905	0.006 millimole per liter (mmol/L) Standard Deviation 0.0861
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen CFB: Chloride	0.7 millimole per liter (mmol/L) Standard Deviation 2.31	1.0 millimole per liter (mmol/L) Standard Deviation 2.31
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen CFB: Cholesterol	-0.02 millimole per liter (mmol/L) Standard Deviation 0.777	0.22 millimole per liter (mmol/L) Standard Deviation 0.735
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen CFB: Glucose	-0.04 millimole per liter (mmol/L) Standard Deviation 1.128	-0.26 millimole per liter (mmol/L) Standard Deviation 1.274
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen CFB: HDL Cholesterol	-0.00 millimole per liter (mmol/L) Standard Deviation 0.188	0.05 millimole per liter (mmol/L) Standard Deviation 0.218
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen CFB: LDL Cholesterol	-0.01 millimole per liter (mmol/L) Standard Deviation 0.636	0.08 millimole per liter (mmol/L) Standard Deviation 0.671
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen CFB: Phosphate	0.009 millimole per liter (mmol/L) Standard Deviation 0.1688	-0.017 millimole per liter (mmol/L) Standard Deviation 0.1937
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen CFB: Potassium	-0.07 millimole per liter (mmol/L) Standard Deviation 0.463	-0.06 millimole per liter (mmol/L) Standard Deviation 0.319
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen CFB: Sodium	0.4 millimole per liter (mmol/L) Standard Deviation 1.99	0.7 millimole per liter (mmol/L) Standard Deviation 2.02
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen CFB: Triglycerides	-0.125 millimole per liter (mmol/L) Standard Deviation 0.9411	0.080 millimole per liter (mmol/L) Standard Deviation 0.8615
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen CFB: Urea Nitrogen	0.33 millimole per liter (mmol/L) Standard Deviation 1.371	-0.11 millimole per liter (mmol/L) Standard Deviation 1.344

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=71 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=79 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Albumin and Protein CFB: Albumin	0.2 grams per liter (g/L) Standard Deviation 2.78	0.4 grams per liter (g/L) Standard Deviation 2.11
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Albumin and Protein CFB: Protein	-1.0 grams per liter (g/L) Standard Deviation 3.60	-0.2 grams per liter (g/L) Standard Deviation 3.09

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=71 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=79 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin CFB: Direct Bilirubin	-0.04 micromoles per liter (µmol/L) Standard Deviation 1.201	-0.25 micromoles per liter (µmol/L) Standard Deviation 1.223
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin CFB: Indirect Bilirubin	-0.39 micromoles per liter (µmol/L) Standard Deviation 2.367	0.15 micromoles per liter (µmol/L) Standard Deviation 2.137
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin CFB: Bilirubin	-0.43 micromoles per liter (µmol/L) Standard Deviation 3.149	-0.10 micromoles per liter (µmol/L) Standard Deviation 2.912
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin CFB: Creatinine	0.7 micromoles per liter (µmol/L) Standard Deviation 8.14	3.0 micromoles per liter (µmol/L) Standard Deviation 9.95

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=71 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=79 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyrotropin	-0.061 milli-international units per liter Standard Deviation 2.2278	-0.181 milli-international units per liter Standard Deviation 1.2943

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=2 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=1 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyroxine Free, Triiodothyronine Free CFB: Thyroxine, Free	2.55 picomoles per liter (pmol/L) Standard Deviation 20.153	6.40 picomoles per liter (pmol/L) Standard Deviation NA Standard deviation could not be calculated due to low number of participants available for analysis.
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyroxine Free, Triiodothyronine Free CFB: Triiodothyronine, Free	0.85 picomoles per liter (pmol/L) Standard Deviation 1.909	1.70 picomoles per liter (pmol/L) Standard Deviation NA Standard deviation could not be calculated due to low number of participants available for analysis.

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=11 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=19 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells CFB: Erythrocytes in Urine	0.9 cells per high power field Standard Deviation 3.30	-0.2 cells per high power field Standard Deviation 2.09
Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells CFB: Leukocytes in Urine	-2.4 cells per high power field Standard Deviation 4.45	0.8 cells per high power field Standard Deviation 7.53
Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells CFB: Renal Epithelial Casts	0.00 cells per high power field Standard Deviation 0.00	0.00 cells per high power field Standard Deviation 0.00
Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells CFB: Squamous Epithelial Cells	-1.3 cells per high power field Standard Deviation 16.29	0.8 cells per high power field Standard Deviation 4.98
Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells CFB: Transitional Epithelial Cells	0.0 cells per high power field Standard Deviation 0.89	0.5 cells per high power field Standard Deviation 1.12

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=11 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=19 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Hyaline Casts	0.9 casts per low power field (/lpf) Standard Deviation 3.56	-0.6 casts per low power field (/lpf) Standard Deviation 1.89

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=68 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=78 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Urinalysis- pH	-0.13 pH Standard Deviation 0.667	0.06 pH Standard Deviation 0.679

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=68 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=80 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Coagulation- Activated Partial Thromboplastin Time, Prothrombin Time CFB: Prothrombin Time	0.14 seconds Standard Deviation 1.008	-0.05 seconds Standard Deviation 0.673
Change From Baseline in Clinical Laboratory Parameters: Coagulation- Activated Partial Thromboplastin Time, Prothrombin Time CFB: Activated Partial Thromboplastin Time	0.86 seconds Standard Deviation 5.876	-1.12 seconds Standard Deviation 2.947

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=68 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=80 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Clinical Laboratory Parameters: Coagulation- Prothrombin International (Intl) Normalized Ratio	0.011 prothrombin intl normalized ratio Standard Deviation 0.1071	-0.011 prothrombin intl normalized ratio Standard Deviation 0.0740

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=68 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=80 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in Electrocardiograms (ECGs) Parameters: Mean Heart Rate	1.3 beats per minute (beats/min) Standard Deviation 9.54	1.6 beats per minute (beats/min) Standard Deviation 8.80

PRIMARY outcome

Timeframe: Baseline; Last value on study (up to 24 months)

Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=68 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=80 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate CFB: PR Interval, Aggregate	-2.8 millisecond (msec) Standard Deviation 13.39	-0.2 millisecond (msec) Standard Deviation 12.94
Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate CFB: QRS Duration, Aggregate	1.8 millisecond (msec) Standard Deviation 9.0	-0.8 millisecond (msec) Standard Deviation 9.11
Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate CFB: QT Interval, Aggregate	-1.4 millisecond (msec) Standard Deviation 22.72	-2.9 millisecond (msec) Standard Deviation 20.94
Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate CFB: QTcF Interval, Aggregate	0.8 millisecond (msec) Standard Deviation 15.32	-0.0 millisecond (msec) Standard Deviation 14.81

PRIMARY outcome

Timeframe: Day 30, Day 60, Day 90, Day 365, Day 395, Safety Follow-up (up to 24 months)

Population: The Safety Set included all participants who were administered IP during the study. Number analyzed is the number of participants with data available for analysis at specified timepoint.

Columbia Suicide Severity Rating Scale evaluates and assesses the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and post-baseline evaluation that focuses on suicidality since last study visit. C-SSRS includes "yes" or "no"' responses for assessment of SI and SB as well as numeric ratings for severity of ideation. If present \[from 1 (minor physical damage) to 5 (death), with 5 being most severe\]. If any of the available assessments in suicidal behavior is Yes, the category is considered as 'Suicidal behavior'. If any of these available assessments in suicidal ideation is Yes but all available assessments in suicidal behavior is NO, the category is considered as 'Suicidal Ideation'. Data is reported for only those timepoints where there was a change in assessment (response) from Baseline. Baseline is the worst of assessments done in any question in SI/SB prior to first dose of IP, excluding lifetime assessment.

Outcome measures

Outcome measures
Measure	Cohort 1 (Direct Rollover) n=72 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=81 Participants Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 30 · No suicidal ideation/behavior to No suicidal ideation/behavior	65 Participants	73 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 30 · No suicidal ideation/behavior to Suicidal ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 30 · No suicidal ideation/behavior to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 30 · Suicidal Ideation to No suicidal ideation/behavior	0 Participants	1 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 30 · Suicidal Ideation to Suicidal Ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 30 · Suicidal Ideation to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 30 · Suicidal Behavior to No suicidal ideation/behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 30 · Suicidal Behavior to Suicidal Ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 30 · Suicidal Behavior to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 60 · No suicidal ideation/behavior to No suicidal ideation/behavior	59 Participants	69 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 60 · No suicidal ideation/behavior to Suicidal ideation	1 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 60 · No suicidal ideation/behavior to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 60 · Suicidal Ideation to No suicidal ideation/behavior	0 Participants	1 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 60 · Suicidal Ideation to Suicidal Ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 60 · Suicidal Ideation to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 60 · Suicidal Behavior to No suicidal ideation/behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 60 · Suicidal Behavior to Suicidal Ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 60 · Suicidal Behavior to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 90 · No suicidal ideation/behavior to No suicidal ideation/behavior	51 Participants	63 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 90 · No suicidal ideation/behavior to Suicidal ideation	2 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 90 · No suicidal ideation/behavior to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 90 · Suicidal Ideation to No suicidal ideation/behavior	0 Participants	1 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 90 · Suicidal Ideation to Suicidal Ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 90 · Suicidal Ideation to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 90 · Suicidal Behavior to No suicidal ideation/behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 90 · Suicidal Behavior to Suicidal Ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 90 · Suicidal Behavior to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 365 · No suicidal ideation/behavior to No suicidal ideation/behavior	20 Participants	31 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 365 · No suicidal ideation/behavior to Suicidal ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 365 · No suicidal ideation/behavior to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 365 · Suicidal Ideation to No suicidal ideation/behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 365 · Suicidal Ideation to Suicidal Ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 365 · Suicidal Ideation to Suicidal Behavior	0 Participants	1 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 365 · Suicidal Behavior to No suicidal ideation/behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 365 · Suicidal Behavior to Suicidal Ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 365 · Suicidal Behavior to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 395 · No suicidal ideation/behavior to No suicidal ideation/behavior	7 Participants	7 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 395 · No suicidal ideation/behavior to Suicidal ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 395 · No suicidal ideation/behavior to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 395 · Suicidal Ideation to No suicidal ideation/behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 395 · Suicidal Ideation to Suicidal Ideation	0 Participants	1 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 395 · Suicidal Ideation to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 395 · Suicidal Behavior to No suicidal ideation/behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 395 · Suicidal Behavior to Suicidal Ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Day 395 · Suicidal Behavior to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Safety Follow-up (up to 24 months) · No suicidal ideation/behavior to No suicidal ideation/behavior	50 Participants	58 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Safety Follow-up (up to 24 months) · No suicidal ideation/behavior to Suicidal ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Safety Follow-up (up to 24 months) · No suicidal ideation/behavior to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Safety Follow-up (up to 24 months) · Suicidal Ideation to No suicidal ideation/behavior	0 Participants	1 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Safety Follow-up (up to 24 months) · Suicidal Ideation to Suicidal Ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Safety Follow-up (up to 24 months) · Suicidal Ideation to Suicidal Behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Safety Follow-up (up to 24 months) · Suicidal Behavior to No suicidal ideation/behavior	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Safety Follow-up (up to 24 months) · Suicidal Behavior to Suicidal Ideation	0 Participants	0 Participants
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Safety Follow-up (up to 24 months) · Suicidal Behavior to Suicidal Behavior	0 Participants	0 Participants

Adverse Events

Cohort 1 (Direct Rollover)

Serious events: 3 serious events

Other events: 46 other events

Deaths: 0 deaths

Cohort 2 (Gap Rollover)

Serious events: 6 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Cohort 1 (Direct Rollover) n=72 participants at risk Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=81 participants at risk Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Psychiatric disorders Suicidal ideation	5.6% 4/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Psychiatric disorders Depression	6.9% 5/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	4.9% 4/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Psychiatric disorders Anxiety	6.9% 5/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	2.5% 2/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Nervous system disorders Balance disorder	5.6% 4/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	3.7% 3/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Nervous system disorders Chorea	5.6% 4/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	3.7% 3/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Psychiatric disorders Insomnia	5.6% 4/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	3.7% 3/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Injury, poisoning and procedural complications Contusion	5.6% 4/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	2.5% 2/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
General disorders Gait disturbance	5.6% 4/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	2.5% 2/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Injury, poisoning and procedural complications Skin laceration	5.6% 4/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	2.5% 2/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Nervous system disorders Somnolence	6.9% 5/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Injury, poisoning and procedural complications Fall	8.3% 6/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	11.1% 9/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Infections and infestations Nasopharyngitis	8.3% 6/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	4.9% 4/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.

Additional Information

Gianpiera Ceresoli-Borroni PhD

Supernus Pharmaceuticals, Inc.

Phone: 3018382521

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort 1 (Direct Rollover) n=72 participants at risk Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.	Cohort 2 (Gap Rollover) n=81 participants at risk Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.
Psychiatric disorders Psychotic disorder	1.4% 1/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Psychiatric disorders Suicidal Ideation	1.4% 1/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Blood and lymphatic system disorders Immune thrombocytopenia	1.4% 1/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	0.00% 0/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Psychiatric disorders Schizoaffective disorder	0.00% 0/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Psychiatric disorders Suicidal behaviour	0.00% 0/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Psychiatric disorders Suicide attempt	0.00% 0/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Injury, poisoning and procedural complications Animal bite	0.00% 0/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Congenital, familial and genetic disorders Huntington's disease	0.00% 0/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Gastrointestinal disorders Constipation	0.00% 0/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Infections and infestations Cellulitis	0.00% 0/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Infections and infestations Pneumonia	0.00% 0/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Nervous system disorders Cerebrovascular accident	0.00% 0/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/72 • Up to 24 months The Safety Set included all participants who were administered IP during the study.	1.2% 1/81 • Up to 24 months The Safety Set included all participants who were administered IP during the study.