Main trial endpoint
constipation, dizziness, sleepiness, hallucinations, insomnia, nausea,, headache
ADVERSE EFFECTS
The main study outcome is the number of side effects observed during the course of treatment. To that end, we constructed a composite adverse effects (cAE) score. The cAE score includes the following 10 symptoms: dizziness (when getting up), sleepiness, insomnia, headache, nausea, vomiting, constipation, drug high, hallucinations, and paranoia. The subjects will score all of these symptoms at the end of each day of treatment on paper or within the electronic data capture system Castor (Castor EDC, Ciwit BV, 