October 22, 2026
Thank you for all your efforts on this study so far!
With the recent release of PA V6.0, the ICF has also been updated to reflect the option for participants to extend participation past WK 78 through WK 112.
When reconsenting, please ensure you discuss the option with the participant. Should the participant be unsure about reconsenting to the extension, they can indicate no at the time of reconsent.
Please ensure you rediscuss the option with continuing around WK 74. If the participant later decides they wish to continue, please perform a reconsent to indicate they have now consented to the study extension.
If the participant consents and later decides they no longer want to continue into the extension, withdraw of consent should be documented.
Reminder, sites are responsible for requesting ICF translations through the Advarra portal.
Thank you to those who participated in the Lifestyle Guidance calls.
THL preservatives in the lab kits DO expire. Please ensure THL vials are stored frozen and review ALL lab kit supply expiration prior to use.
Please be on the lookout for upcoming invites regarding PAV6.0 site training. We have three meeting options, please join one meeting as attendance is mandatory. The meeting times are as listed below:
Please see the link to the form below to submit any questions you’d like to review during the upcoming meetings.
Site staff/PIs should be reviewing study criteria for contraception with both males and females throughout the study and document in source participant response. We’ve previously sent reminders about female contraception requirements.
As a reminder male contraception guidance is as follows:
Pregnancy reporting guidelines for females and males with pregnant partners are as follows, please ensure you are reporting pregnancies per protocol guidelines.
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