11. Patients must be on a stable dose of any allowed chronic concomitant medications while participating in the study, as described in protocol. This is defined as no changes in medication for at least 60 days prior to Day 1 and no changes in dose for at least 30 days prior to Day 1; Note that stable concomitant usage (>3 months) of growth hormone, hormone replacement therapy, GLP-1 agents, statins, or other medications (excluding insulin, modafinil, anti-psychotics), and other medications commonly used in PWS patients are allowed (See Section 6.4.5 on Concomitant medications).