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Protocol Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Neravex (CLT-105) in Adults with Generalized Anxiety Disorder (GAD)
Clarion Therapeutics
123 Road St East
Toronto, Ontario, Canada
A1A 1A1
Medical Advisor
Sousa, Michael
Tel: +1-416-555-5555
Section 5.2
EXCLUSION CRITERIA
Subjects meeting any of the following criteria will be excluded from participation in this study:
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Based on Section 5.2 of the protocol, the key exclusion criteria are:
- Current diagnosis of Major Depressive Disorder (MDD)
- History of bipolar, schizophrenia, or psychotic disorders
- Active suicidal ideation (C-SSRS score ≥ 4)
- Known hypersensitivity to CLT-105
- Use of prohibited medications (MAOIs, benzodiazepines) within 14 days
Referenced from page 8, Section 5.2
6.2 VISIT SCHEDULE
Subjects will attend the clinic for scheduled visits as outlined in the Schedule of Assessments.
Visit 3 (Day 15): Subjects must attend within a window of ±3 days (Day 12 to Day 18). All assessments including vital signs, ECG, and laboratory draws must be completed during this window.
6.2.1 Unscheduled visits may be performed at the investigator's discretion if clinically indicated.
6.3 STUDY PROCEDURES
A detailed listing of all procedures to be performed at each visit is provided in the Schedule of Assessments (Section 6.1).
What is the visit window for Visit 3?
Visit 3 Window Period:
Day 15 ± 3 days (Day 12 to Day 18)
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| Capability | Manual Process | Protocol AI |
|---|---|---|
| Protocol Lookup | Ctrl+F through 200+ pages | Instant AI-powered answers |
| eCRF Creation | 4-6 weeks manual build | Auto-generated in hours |
| Visit Schedule | Manual extraction & spreadsheets | AI-extracted, calendar-ready |
| Edit Checks | Line-by-line rule writing | Auto-generated from protocol |
| Amendment Impact | Manual redline comparison | Instant diff + impact analysis |
| Team Onboarding | Read entire protocol, days of training | Interactive AI training mode |
| Citation Accuracy | Depends on reviewer | Precise page & section refs |