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

IP Expiry Memo Follow UP

The IP expiry memo sent out in the 02Apr2026 study update with a document date of 31Mar2024 was incorrect. The date in the document was a typo and has since been corrected. Please see attached the updated IP expiry memo which was sent via email.    

Protocol Amendment V5.0 Materials

PA V5.0 materials have been shipped to sites. If additional materials are needed, please submit a study re-supply form.  

Vitamin Deficiency Reporting

Regarding participants with vitamin deficiencies, please report when lab findings are deemed clinically significant. If participant has lab results that are slightly out of range and can be treated with a multivitamin, nutritionist, etc. please refrain from logging as an Adverse Event of Special Monitoring, and update EDC notes accordingly. If findings are deemed to be clinically significant, please also include supplementation or intervention started to address deficiency in EDC.  

MRL Malnourishment Assessments  

MRL has noted an uptick in problem samples for the malnourishment assessment samples below. To ensure your malnourishment assessment samples can be tested and resulted, please follow the instructions below:

• Vitamin B2 must be collected in a LiHep Plasma tube and have “Li Hep Plasma” written on the sample label or requisition form to be accepted. Please refer to MRL memo issued on 25-Mar-2026 for further guidance. Shipments of corrected supplies are forthcoming.

• Vitamin  B7 requires 2.0mL for testing. Samples with less volume may result as QNS.  

• Vitamin K1 has a preferred volume of at least 1.0mL. Samples with less volume may result as QNS.