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

Protocol Clarification Letter #5

Participants transitioning to autoinjectors before Week 34 requires collection of PHQ-9 and C-SSRS to support safety evaluation.  

• If transitioning at Week 26, shift collection from Week 27 to Week 26 (since these subjects will not have an in-clinic Week 27 visit). Otherwise, for those transitioning at or after Week 30, collect assessments at Week 27.  

• The week 30 collection of assessments will remain, as is, regardless of transition visit.  

• If transitioning at Week 26 or Week 30, shift collection of assessments from Week 33 to Week 34 (since these subjects will not have an in-clinic Week 33 visit).  

• For those that transition at Week 34, this assessment will remain at Week 33.

ePRO assessments EQ-5D-5L, SF36V2 acute, IWQOL-Lite-CT, WPAI-GH, Treatment Satisfaction and Intention to Adhere are not expected until week 34 regardless of the transition date.

Study Protocol Clarification & Administrative Letters  

To assist your team in reviewing ISF documents and ensuring accuracy, please see the comprehensive listing of protocol clarification and administrative letters for the study below for your records.

18-Apr-2025 Protocol Clarification letter #01

21-May-2025 Protocol Administrative letter #01

30-Jul-2025 Protocol Clarification letter #03

19-Sep-2025 Protocol Clarification letter #04

11-Dec-2025 Protocol Administrative letter #02

10-Mar-2026 Protocol Clarification letter #05

19-Mar-2026 Protocol Clarification letter #06

IP Expiry Extension Memo  

Please see previously sent email for attached the IP expiry memo which notes the extension of the expiration for IP vials through October 2026.  

Updated Medpace Study Team List  

Please see oreviously sent email for attached V2.0 of the Medpace study team listing. Please ensure this is filed to your site ISF binder.

MRL Assessment Testing Follow-up  

The turnaround times for malnourishment assessment testing can be found in section 5.1.1 of the lab manual:  

Sample Name | Analytical Laboratory | Test(s) | Turnaround Time

Malnourishment Chemistry | MRL-US | Prealbumin | Daily Mon-Fri; Samples received on Saturday will be tested the following Monday

Vitamins: B12 / D / Folate / A / E  | MRL-US | Vitamin A, Vitamin E | Batched Monthly

Vitamins: B12 / D / Folate / A / E  | MRL-US | Vitamin B12, Vitamin D, Vitamin B9 (Folate) | Batched Weekly - TAT 8 days

Vitamin B3 / B7 | NMS | Vitamin B3 | 3-6 days

Vitamin B3 / B7 | NMS | Vitamin B7 | 5 days

Vitamin C | ARUP | Vitamin C | 1-6 days

Vitamin B2 | ARUP | Vitamin B2 | 1-6 days

Vitamin B1 | ARUP | Vitamin B1 | 2-5 days

Vitamins: B6 / K1 / iPTH | MRL-US | iPTH | Batched Weekly

Vitamins: B6 / K1 / iPTH | ARUP | Vitamin B6 | 1-5 days

Vitamins: B6 / K1 / iPTH | ARUP | Vitamin K1 | 2-5 days

Zinc/Copper | NMS | Zinc | 3-7 days

Zinc/Copper | NMS | Copper | 7 days

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