A study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational medication - these may include how well an investigational medication works for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.

A study is the process by which new and innovative medications, interventions, and treatments are approved and brought to the general public, so people can hopefully live happier and healthier lives. Even over-the-counter medications, such as aspirin that you may have used to counteract a headache, have gone through the clinical research study process before they were available at your local pharmacy.

The Monarch Study will evaluate how effective a study drug is in treating the symptoms of PTSD when given in different doses compared to a placebo. The results from this study will be used to develop future studies for PTSD.

The total duration of the study for each participant will be approximately 18 weeks. During the screening period, which will occur over a period of up to 28 days, the study doctor will ask participants some questions and do some tests to see if they are eligible for the study.

If qualified, participants will be randomly assigned, like drawing straws, to one of three treatment groups to take either one of two doses of the study drug or a placebo. A placebo is a tablet that looks like the study drug but contains no active ingredients. This study is double-blind, which means that neither participants nor the study doctor will know which treatment they are taking during the study. Participants will have a clinic visit and be given a supply of study drug to take home.

The treatment period will take 12 weeks to complete and includes 7 clinic visits (up to 4 hours each visit) and 3 phone calls with the study doctor. During this period of the study, participants will take their study treatment once a day at home as instructed by the study doctor.

A safety follow-up visit will occur 2-weeks after the treatment period is completed. During the period of the study, participants will have a visit at the clinic for some tests and procedures.

Volunteers who qualify to take part in the study may receive reimbursement for time and travel. Please discuss with the study team.

There is no cost to participate in the Monarch Study. If you are eligible and decide to take part:

• You will receive study-related care from a team of experienced doctors and nurses throughout the study
• All study-related visits, tests, assessments, and investigational medication will be provided at no cost to you

The research team will be able to explain more about what the Monarch Study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Your decision to participate or not participate will have no effect on the medical care you receive now or in the future. If you are eligible and choose to participate in the Monarch Study, you may leave the study at any time without providing any reason.

If you are interested in participating in the Monarch Study and to find out if you may qualify, contact a study site location near you.