Health testing with all subjects who participated in any phase I clinical study and received at least one dose of HTL0018318/AGN-242071 to date.

This programme is designed to provide targeted health testing procedures to all
subjects who participated in any phase 1 clinical studies with
HTL0018318/AGN-242071 and received at least one dose of active
HTL0018318/AGN-242071 to date.
This testing is being provided by the Sponsor following emerging non-clinical
safety findings (liver abnormalities) from a 9-month toxicology study, in
non-human primates, with HTL0018318/AGN-242071.

Because the risk of liver abnormalities for subjects who previously took
HTL0018318/AGN-242071 is unknown the sponsor has decided that it is prudent to
offer this initial 6-month health testing programme while further investigation
of the toxicity findings and their translatability to humans is being
investigated.

This programme will provide targeted health testing, including blood tests for
indicators of general health and liver ultrasound (the liver was the primary
target in the 9-month monkey study), for individual qualifying subjects who are
only those previously exposed to at least one dose of HTL0018318/AGN-242071.

The primary aim of the programme is to establish an initial baseline as soon as
possible, followed by another assessment after at least 6-months, to observe
each subject*s general health and the status of their liver via blood and
abdominal ultrasound tests. The secondary aim of the surveillance will be to
establish any discernible patterns in the subjects* health which may have
relevance to the non-clinical safety findings.

Test results will be used to assess each individual and, where abnormalities
are identified, refer them for further testing and/or treatment per local
standard of care.

This programme is focused on tracking the health of individual subjects over a
period of at least 6-months and is not intended as a cohort study and there is
no prospective intention to do any group/sub-group analyses.

This is a programme to provide health assessments, on 2 occasions, at least
6-months apart (no less than 6-months and no longer than 8-months), to all
subjects who received at least one dose of active study medication in any prior
HTL0018318/AGN-242071 clinical study, and to document the findings in
individual subject narratives.

This testing programme does not involve the provision of any medication or
other experimental procedure and so participation will involve minimal
additional risk to the participants. It is anticipated that some subjects may
experience psychological distress or anxiety when the non-clinical safety
findings are disclosed to them. Investigators will be advised on providing this
information to subjects and also advised to provide adequate support for
subjects so as to minimize this risk.

While there will also be no direct therapeutic benefit to subjects they may
benefit from earlier detection of previously undetected health issues as a
result of this health testing programme