Inclusion Criteria
- Participants must have completed the double-blind treatment period (ie, Visit 8) of
Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or
CN0120045, without an adverse event (AE) that, in the investigator's opinion, may
indicate an unacceptable safety risk.
Exclusion Criteria
- Participants must not have a significant risk of committing violent acts, serious
self-harm, or attempting suicide based on history or routine psychiatric status
examination, or those who are homicidal or are considered to be a high risk to
others, or who have an answer of "Yes" on Questions 4 or 5 on the suicidal ideation
section of the "Since Last Visit" version of the C-SSRS at baseline (Visit 1).
Nonsuicidal, self-injurious behavior is not exclusionary.
- Participants must not have any clinically significant abnormality including any
finding(s) from the physical examination, vital signs, ECG at the end of treatment
visit of Study CN0120020, CN0120044, or CN0120045 that the investigator, in
consultation with the Sponsor Medical Monitor, would jeopardize the safety of the
participant.
- Participants must not have either a systolic blood pressure (sBP) or diastolic blood
pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the
presence or absence of symptoms.
- Other protocol-defined Inclusion/Exclusion criteria apply.
