The purpose of this clinical study is to assess the efficacy and safety of an investigational drug. The word “investigational” means that the study drug is still being tested in research studies and is not approved by a Health Authority.

Randomization is a process used to assign you by chance, to one of the study groups. Neither you nor your doctor can choose which group you are in.

Placebo-controlled means this study will be designed with placebo group, and to be compared with a study drug to learn if the study drug has any real effect.

Double-blind means that neither your trial doctor nor you will know which group of treatments you are receiving during Part 1.

If you agree to take part in the clinical trial, you should go to your visits as scheduled by the study team to complete the study procedures and take the study drug as directed by the study team.

The participation is voluntary, and you are free to withdraw from this clinical study at any time you wish.