This study requires
The treatment you get will be chosen by chance, like flipping a coin. You will have an equal chance of being given each treatment. You will be randomly assigned to either the INS1007 10-mg, or 25-mg treatment groups, or the placebo treatment group. A placebo is a medication with no active ingredients. It looks the same as the active ingredient tablet but it is not. Neither you nor the study doctor will know which treatment you are getting.
The study will be explained to you before any study-related tests and procedures are done.
The following is an overview of the study visits required. The study team will discuss the specific study-related procedures for each visit with you.
Screening Period (Visit 1)
Visit 2 (Baseline, Day 1) Randomization
Visit 3 (Week 2, Day 15)
Visit 4 (Week 4, Day 29)
Visit 5 (Week 8, Day 57)
Visit 6 (Week 12, Day 85)
Visit 7 (Week 16, Day 113)
Visit 8 (Week 20, Day 141)
Visit 9 (Week 24, Day 169, End of Treatment)
Visit 10 (Week 28, Day 197, End of Study)