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. The date should be 31Mar2026 and this error has since been correct. Please see the updated IP expiry memo previously attached via email.  

PI Medical Monitoring Drop-In Q&A Log  

Please see the Q&A log from the PI/MM drop-in session meetings previoulsy attached via email for your reference. If you have additional questions, please reach out to your CRA or the medical monitoring team.

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 patients with vitamin deficiencies, please report and flag when lab findings and deemed clinically significant. If patients findings are out of range and can be treated with a multivitamin, nutritionist, etc. please refrain from logging as an Adverse Even of Special Interest, and update EDC notes accordingly.  

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