Study design and procedures
The IB1001-301 clinical trial is a double-blind placebo-controlled crossover trial. Patients will be first assessed during a baseline period (with or without a study run-in) and randomized (1:1) to one of two treatment sequences: IB1001 followed by placebo, or vice-versa. Each treatment period will last approximately 12 weeks (84–91 days). Patients will be assessed twice during each period to allow an assessment of intra-patient variability.