Thank you for all your efforts on this study so far! 

Lifestyle Guidance and Q&A  

Thank you to those who have joined our first option on Tuesday, 06Oct2026. If you have yet to join, please join one of our following options.  

Option 2 – Friday, 09Oct2026 3-3:45 PM ET  

Option 3 – Monday, 12Oct2026 2-2:45 PM ET

Data Management Update – Participant Discontinuation  

Please see instruction below regarding reason for participant discontinuation.  

• Review dropdown options for Primary Reason of Discontinuation closely

• When possible, the option with the most specificity should be chosen over “Withdrawal by Subject”, “Physician Decision”, or “Other”.

• Example: If primary reason is for perceived lack of efficacy, consider selecting “Lack of Efficacy” instead of “Withdrawal by Subject”

• Similar consideration should be given for options like “Met Protocol Defined Minimum BMI”, “Goal Weight Met”, etc.

Study Procedure Reminders – Vitals  

Please see below section 8.2 of the protocol regarding rest requirements prior to completing other study procedures. The study expectation is participant will sit for 5 minutes prior to vital signs in a quiet setting without distractions. During this time other study procedures such as ePROs or mental health questionnaires should not be completed by the participant.  

If you have any further questions, please feel free to reach out to your site’s assigned CRA.  

Study Supply Request Form V5.0  

Please see previous email for the attached V5.0 of the 301-study supply resupply request form.  

• Please file this to your site ISF binder, and ensure to use this form when requesting supplies, email this completed form to the Medpace Project Coordinator: L.Sheffield@medpace.com; E.Fox2@medpace.com; E.Szucsik@medpace.com; S.Gordon@medpace.com. 

Updated Study Team Listing  

Please see previous email for the attached updated study team listing. Please ensure this is filed to your site ISF binder.