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

Study Reminders

Enrollment Open

• New year, new you!! Recruitment remains open as we are close to 70% enrolled! We will continue to keep you informed on the progress but encourage you to target patients and tie in recruitment efforts with the renewed focus on health and wellness.  

Sharps Containers and Coolers Shipments

Please be advised, beginning this week, sites will begin to receive sharps containers to support the roll out of autoinjectors in Mar-2026. Following this order the coolers (containing 2 freezer packs each) will be sent around Feb-2026. The initial shipment sent will be a small bolus, then the rest of the materials will be shipped piecewise.

• Boxes of 12 coolers per shipment according to patient count. One cooler per participant will be distributed at the first dispensing visit with the autoinjectors. The site will need to cool the ice packs ahead of the first visit when the cooler is provided. At future visits, the participant is expected to return with the cooler and ice packs pre-cooled for new dispensation. Please ensure you remind the participants each visit of these expectations.  

• Dimensions: 8.6 x 7.1 x 7.1 in

• Below is the sample autoinjector that will be placed in the coolers at dispensing visits.

• Dimensions: 6-3/16" x 3" x 1-1/4" 

• Each box includes 100 sharp containers which will be distributed to sites according to participant enrollment. Participants should be given one sharps container at each dispensing visit. The participant should return to the next visit with the sharps container including the used sharps/autoinjectors. The site should keep the sharps container onsite with the used autoinjectors until the CRA performs reconciliation and then it can be destroyed per the Pharmacy Manual.  

• Dimensions: 3x3x6in (LxWxH)

End of Study Stipend – Clarification  

Please be advised the ICF updates were correct and do not require further updates, but the previous email communication noted incorrect corresponding study weeks. Kindly make note the stipend is available for all subjects as outlined in the PCS policy to be paid after DOV entry at 3 visits: Week 34 (Visit 36), Week 58 (Visit 42), and Week 84/EOS (Visit 48).

• The visit numbers listed in parathesis above are included in the ICF template language. These numbers are correct and do not require any changes. 

The end of study stipend has been adjusted to $250 at 3 visits: Week 34 (Visit 36), Week 58 (Visit 42), and Week 84/EOS (Visit 48) for a total of $750. These payments will be provided by Medpace PCS* for sites who are utilizing the service.  

Regarding any questions, please reach out to your assigned CRA for further support!

*Sites not utilizing PCS are covered to invoice for the stipend under the terms of the site CTA process for ‘Additional Study-necessitated Fees’. A contract amendment is not required to specifically note these fees.

PI/CRC Call

• Previously attached via email, you will find the Q&A and slides from the PI/CRC call in Dec-2025.