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If you choose to
participate, your involvement will last for approximately 7 months. During this
time, you will have at least eight study visits (not including the optional
open-label extension, which could last up to 5 years).
Screening period (around 1
month)
We'll carry out some health assessments to see if you and
the study are a good fit for you.
Double-Blind treatment
Period (around 3 months)
If you're eligible and decide to join, you will be randomly
assigned to one of two groups: there is a 60% chance of being in Group 1
(receiving the investigational medication) and a 40% chance of being in Group 2
(receiving a placebo).
You'll be given your
assigned medicine as an intravenous (IV) infusion
Optional open-label
extension (OLE)
Once you've completed the treatment period, you may be able to join the OLE. Everyone who joins the OLE will be given the investigational medicine as subcutaneous injections, even if they were previously given the placebo. The OLE phase will continue until the study ends