Randomization Criteria. The following additional criteria must be met prior to randomization and dispensing of study medication to subjects:
Randomization Criteria. All of the following must be met before the patient is eligible for randomization at Visit 2:
Randomization Criteria. Once all pre-randomization assessments have been completed, only those patients who meet all of the following randomization criteria will be eligible to continue:
1. Patient continues to meet all inclusion and exclusion criteria, including urine and blood test results, and
2. Visit 2 total CAPS-5 score ≥ 33 (“Symptom Severity” version using 1-week recall), and
3. At Visit 2, patient is not severely depressed (based on the investigator’s judgment and Visit 2 C-SSRS, CAPS-5, and BDI-II, and considering the pre-randomization collaborative review by the investigator and medical monitor(s) of the patient’s Visit 1 psychiatric history, presenting symptomatology, M.I.N.I. 7.0.2, C-SSRS, CAPS-5, and BDI-II assessments).
4. No active suicidal intent or plan, based on Investigator’s judgment, and Visit 2 C-SSRS responses (e.g., no C-SSRS Type 4-5 ideation or suicidal behavior since Visit 1). If the patient does not satisfy these randomization criteria, the patient has failed to qualify for this study and should be considered a screen failure, with the reason documented. With Medical Monitor approval, if the patient is otherwise considered a qualified and compliant patient, Visit 2 may be delayed to accommodate situations in which extenuating or short-term circumstances do not warrant screen failure. If the patient does satisfy these randomization criteria, then continue with the following: • Randomize the patient via IWRS Randomization System • Dispense 4-week supply (two bottles) of double-blind study medication • Review patient instructions regarding study drug dosing (Section 9.2) • Schedule next study visit
Randomization Criteria. Subjects that meet all Inclusion/Exclusion criteria listed above will be enrolled in this double-blind study. Upon approval by the medical monitor and sponsor, subjects who do not qualify based on a reversible medical condition or mild intercurrent illness may be re- evaluated after further testing/examination or re-screened after the condition is resolved.
Randomization Criteria. The following additional criteria must be met prior to dispensing treatment to trial subjects:
Randomization Criteria. The following randomization criteria must be satisfied at the Visit 2 Baseline Randomization Visit in order for the patient to be eligible to continue in the study. Only those patients meeting all of the following randomization criteria are eligible for randomization:
1. Patient continues to meet all inclusion and exclusion criteria, including urine and blood test results, and
2. Visit 2 total CAPS-5 score ≥ 33 (“Symptom Severity version using 1-week recall), and
3. At Visit 2, patient is not severely depressed (based on the investigator’s judgment and Visit 2 C-SSRS, CAPS-5, and BDI-II, and considering the pre-randomization collaborative review by the investigator and medical monitor(s) of the patient’s Visit 1 psychiatric history, presenting symptomatology, M.I.N.I. 7.0.2, C-SSRS, CAPS-5, and BDI-II assessments).
4. No active suicidal intent or plan, based on Investigator’s judgment, and Visit 2 C- SSRS responses (e.g., no C-SSRS Type 4-5 ideation or suicidal behavior since Visit 1).
