1. Patients with history of Major Depressive Disorder (MDD) within six months prior to the Screen Visit, or a score of greater than or equal to 14 on the Beck Depression Inventory II (BDI-II), or a history of suicidal behavior or suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS®). If a psychiatrist or psychologist, using clinical judgment, believes a patient who scored between 14 and 19 on the BDI®-II is not depressed, the patient may be entered into the trial. NOTE: If a patient reports positive response to BDI®-II Question 9 and/or a Yes response to either C-SSRS® Suicide Ideation section Question 1 and/or 2 and/or any question in the Suicide Behavior section, please refer to Section 5.2.5 for immediate actions required.