Common use of Secondary Objectives Clause in Contracts

Secondary Objectives. The following objectives will compare full dose subjects to low dose subjects in Stage 1: • Assess changes in self-reported PTSD symptoms in participants receiving the full dose and low dose MDMA as measured with the PTSD Diagnostic Scale (PDS) at baseline, after each experimental session and/or the primary endpoint. • Assess depression symptoms with the ▇▇▇▇ Depression Inventory- II (BDI-II) at baseline and the primary endpoint. • Assess quality of life with the Global Assessment of Functionality (GAF) at baseline and the primary endpoint. • Assess self-reported sleep quality with the Pittsburgh Sleep Quality Index (PSQI) at baseline and the primary endpoint. The following objectives will compare effects in specified subjects: • Assess PTSD symptoms via CAPS and PDS, depression symptoms via BDI-II, quality of life via GAF and sleep quality via PSQI throughout Stage 2 in comparison to Stage 1 in crossover subjects. • Assess long-term effects of MDMA-assisted psychotherapy on symptoms of PTSD, depression, sleep quality, and global function via CAPS and PDS, BDI-II, PSQI and GAF one year after the final experimental session for each subject. The following objectives will include exploratory analyses intended to inform protocol design: • Explore the effects of each experimental session upon self-reported changes in consciousness, as those associated with a transformational or mystical experience via the States of Consciousness Questionnaire (SOCQ). • Assess the effect of the third experimental session for full dose subjects in Stage 1 and Stage 2 using CAPS, PDS, BDI-II, GAF and PSQI. • Assess the ability of the investigators and subjects to accurately guess condition assignment in Stage 1. • Correlate adherence to the treatment manual with Global CAPS scores using adherence criteria ratings to assess videos of psychotherapy sessions. • Correlate development of therapeutic alliance with Global CAPS scores using the Segmented Working Alliance Inventory-Observer Form (S-WAI-O) to assess videos of psychotherapy sessions.

Secondary Objectives. The following objectives will compare full dose subjects to low comparator dose subjects in Stage 1: • Assess changes in self-reported PTSD symptoms in participants receiving the full dose and low dose MDMA as measured with the PTSD Diagnostic Scale (PDS) at baseline, after each experimental session and/or the primary endpoint. • Assess depression symptoms with the ▇▇▇▇ Depression Inventory- II Inventory (BDI-II) at baseline and the primary endpoint. • Assess quality of life global functioning with the Global Assessment of Functionality Functioning (GAF) at baseline and the primary endpoint. • Assess changes in personality with the Neuroticism Extroversion Openness Personality Inventory (NEO-PI) at baseline and the primary endpoint. • Assess self-reported sleep quality with the Pittsburgh Sleep Quality Index (PSQI) at baseline and the primary endpoint. • Assess self-reported dissociation symptoms with the Dissociation Experiences Scale II (DES-II) at baseline and the primary endpoint. • Assess self-reported posttraumatic growth with the Posttraumatic Growth Inventory (PTGI) at baseline and the primary endpoint. The following objectives will compare effects in specified subjects: • Assess PTSD symptoms via CAPS and PDS, depression symptoms via BDI-II, quality of life global functioning via GAF and GAF, sleep quality via PSQI PSQI, posttraumatic growth via PTGI, changes in personality via NEO-PI and dissociation symptoms via the DES-II, throughout Stage 2 in comparison to Stage 1 in crossover subjects. • Assess long-term effects of MDMA-assisted psychotherapy on symptoms of PTSD, depression, global function, sleep quality, posttraumatic growth, and global function dissociation symptoms via CAPS and CAPS, PDS, BDI-II, PSQI GAF, PTGI, PSQI, PTGI (in reference to start of the study), DES-II, and GAF changes in personality via NEO-PI one year after the final experimental session for each subject. The following objectives will include exploratory analyses intended to inform protocol design: • Explore the effects of each experimental session upon self-reported changes in consciousness, as those associated with a transformational or mystical experience via the States of Consciousness Questionnaire (SOCQ). • Assess the effect of the third experimental session for full dose subjects in Stage 1 and Stage 2 using CAPS, PDS, BDI-II, GAF GAF, PSQI, PTGI, NEO-PI, and PSQIDES- II. • Assess the ability of the investigators Clinical Investigators and subjects to accurately guess condition assignment in Stage 1. • Correlate adherence to the treatment manual with Global CAPS scores using adherence criteria ratings to assess videos of psychotherapy sessions. • Correlate development of therapeutic alliance with Global CAPS scores using the Segmented Working Alliance Inventory-Observer Form (S-WAI-O) to assess videos of psychotherapy sessions.