Amendment 2 makes several changes to the study design and a number of changes to protocol text prior to the start of the study. The protocol has been amended to include the addition of two new outcome measures, the Neuroticism Extroversion Openness Personality Inventory and the States of Consciousness Questionnaire, and updates terminology and measures to the most current version. This amendment revises language describing randomization, adverse event and concomitant medication collection, and visit scheduling to improve clarity. This amendment also adds two new inclusion criteria, in addition to improving wording for an inclusion criterion and audio and video recordings. The amended protocol no longer specifies that attendants match participant gender. Participants will receive memory aid cards to assist in their recall of any adverse events or medications when assessed at 12 month follow-up.
