September 17, 2026
Thank you for all your efforts on this study so far!
Female Participants of childbearing potential (WOCBP) must be non-pregnant and non-lactating and must use an acceptable-highly effective method of contraception (as described in Table 18) from Screening until at least 90 days after the last dose of IP.
As a reminder, the following are highly effective contraceptive methods, please ensure the participants chosen form is entered in EDC.
User dependent methods: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), and Progestogen only hormonal contraception associated with inhibition of ovulation (oral or injectable)
IMPORTANT NOTE: Oral hormonal contraception may be susceptible to interaction with the study treatment, which may reduce the efficacy of the contraceptive method. Therefore, in addition to the oral hormonal contraceptive, an additional barrier contraceptive method (male/female condom with spermicide, diaphragm, cervical cap, or sponge) must be used during the treatment period and for at least 90 days after the last dose of study treatment.
If your site needs to assign a replacement Autoinjector to a participant, please use the “Assign Replacement Study Product” action in ClinTrak IRT (see screen snippet below). The system will prompt you to enter the specific Autoinjector ID to replace. This ensures the system assigns a replacement kit of the same strength.
Do not use the “Record Unscheduled Autoinjector Assignment (Part B Participants Only)” action to assign replacement kits. This action should be reserved for unscheduled autoinjector assignments between scheduled Monthly visits due to restarting IP, dose modification, or to assign kits to participants coming in for weekly Autoinjector assignments.
Please ensure the correct sample barcode labels are being applied to all tubes ahead of shipment to MRL. Unlabeled or incorrectly labeled samples are at risk of rejection.
The Malnutrition assessment lab panel includes vitamin C testing. It is critical that Vitamin C samples are protected from light and frozen as soon as possible within 1 hour of collection, as indicated in the QRC and Lab Manual. Refer to the QRC/Lab manual for full sample processing instructions. Vitamin C degradation occurs rapidly if the sample is exposed to light or unfrozen, which can lead to erroneously low Vitamin C results.
Previously attached in an email you will find the Q&A from the drop in calls earlier this month.
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