To determine the relevance of the study to real-life patients, it is important to examine the inclusion and exclusion criteria of the trial. The main inclusion criteria are discussed above. Patients excluded from the trial were women who were pregnant or of child-bearing age but unwilling to use an effective contraceptive method. Exclusion criteria also included major medical conditions, bipolar disorder, psychosis, panic disorder, concurrent major depressive disorders, generalized anxiety disorder, history of alcohol or other drug dependency within the previous 12 months, serious suicidal risk, previous non-response to two or more adequate antidepressant trials, and use of psychotropic drugs within 2 weeks of enrolment. The use of the study results will have to take these inclusion and exclusion criteria into account, and the clinician needs to judge the relevance of the results for the individual patient.
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