3.5. Adverse Events
nausea, rash, constipation
ADVERSE EVENTS
No serious adverse events occurred during the study. One patient developed a vesicular, pruritic generalized skin rash accompanied by a diminished ability to concentrate and constipation which lasted throughout the entire placebo-dosing period and was related to the colorant in the placebo preparation. Moderate nausea following placebo ingestion was noted in two patients in the first week of dosing.