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Questions and Answers
What is the minimum washout period for medications like anticonvulsants, mood stabilizers, and psychostimulants before the first dose of study drug?
What is the minimum washout period for medications like anticonvulsants, mood stabilizers, and psychostimulants before the first dose of study drug?
Why would a longer tapering/washout period be allowed for certain medications?
Why would a longer tapering/washout period be allowed for certain medications?
What is not allowed within 4 weeks of the first dose of study drug?
What is not allowed within 4 weeks of the first dose of study drug?
During which period are ergometrine and xanthine-derivative medications not allowed?
During which period are ergometrine and xanthine-derivative medications not allowed?
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What is the criteria for exclusion of certain medications during the study?
What is the criteria for exclusion of certain medications during the study?
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What happens if a participant is taking a medication that is not allowed during the study?
What happens if a participant is taking a medication that is not allowed during the study?
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How many standard units of alcohol are subjects permitted to consume per day?
How many standard units of alcohol are subjects permitted to consume per day?
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How long must subjects have been on a stable dose of oral antidepressant medication by the time of Screening?
How long must subjects have been on a stable dose of oral antidepressant medication by the time of Screening?
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What information should be included in the documentation for each medication?
What information should be included in the documentation for each medication?
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What is not permitted during the DB Period of the study?
What is not permitted during the DB Period of the study?
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What should be done with as-needed prescriptions during the trial?
What should be done with as-needed prescriptions during the trial?
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What can be adjusted or switched in the OLE Period according to the Investigator's clinical judgment?
What can be adjusted or switched in the OLE Period according to the Investigator's clinical judgment?
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What type of medications are prohibited during the DB Period and OLE Period of the study?
What type of medications are prohibited during the DB Period and OLE Period of the study?
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Why must subjects taper-off other medications if they are taking more than 1 oral antidepressant?
Why must subjects taper-off other medications if they are taking more than 1 oral antidepressant?
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What is required for chronic users of benzodiazepines, benzodiazepine-like drugs, and/or prescription sleeping aids?
What is required for chronic users of benzodiazepines, benzodiazepine-like drugs, and/or prescription sleeping aids?
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Why are COVID-19 vaccines recorded as concomitant medication?
Why are COVID-19 vaccines recorded as concomitant medication?
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Who decides the length of the tapering schedule and washout period for chronic users of prohibited medications?
Who decides the length of the tapering schedule and washout period for chronic users of prohibited medications?
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When should episodic users of benzodiazepines, benzodiazepine-like drugs, and/or prescription sleeping aids undergo a washout period?
When should episodic users of benzodiazepines, benzodiazepine-like drugs, and/or prescription sleeping aids undergo a washout period?
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