Quest Diagnostics

• The planned number of investigative sites was increased from 40 to 55.
• Weekly waking saliva collection was removed because of practical feasibility challenges and to reduce participant burden.
• Scheduled telephone contacts were reduced to lessen participant burden, while targeted as-needed contacts were retained or added for dose escalation, glucocorticoid tapering, safety monitoring, and compliance follow-up.
• COVID-19 mitigation measures allowed remote study visits and screening by telemedicine or at the participant's home where locally approved.
• Screening information collected within 45 days before Day 1 could be used when necessary, and screening data from the parallel SPR001-204 study could be transferred for eligibility determination.
• Eligibility criteria were revised to remove the elevated ACTH requirement, expand the acceptable glucocorticoid replacement range to 15-60 mg/day hydrocortisone equivalent, and update diagnostic and A4 requirements.

These findings describe the trial, not the service provider’s performance or responsibility.

• The trial enrolled 185 participants at 41 centres across Germany, France, Italy, and Spain.
• A 2022 protocol amendment enlarged the eligible population, reduced protocol complexity, and revised eligibility criteria to align with current ofatumumab and other DMT product information.
• A 2021 protocol amendment required full routine laboratory testing at every on-site visit from baseline through Month 15.

These findings describe the trial, not the service provider’s performance or responsibility.