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From a pharmacological perspective, potential interactions should be considered

Use of prescription medicinal products or non-prescription drugs or herbal products (including St Johns wort), except for highly effective contraceptive methods, hormone replacement therapy, routine vitamins, topical medication not reaching the systemic circulation, and occasional use of paracetamol, was not permitted from within 14 days prior to the day of screening to 24 h after the last dosing

The process takes 13 weeks

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Lumbar puncture (LP) demonstrated an opening pressure of 32.5 cm H2O, and the subsequent cerebrospinal fluid (CSF) analysis was unremarkable