Randomization
At visit 2, patients will be randomized (1:1) to their respective sequence. Patients will be centrally randomized using Medpace’s ClinTrak Interactive Response Technology (IRT) web-based system. Medpace is responsible for the generation of the allocation sequence, and the IRT system will automatically assign participants to their respective sequence. The study utilizes a permuted block design for randomization. The LIVE randomization list is generated by an independent statistician based on the approved randomization plan. As the study is double-blinded, patients, their families, the study team, and the sponsor will be blinded to the randomization scheme and the sequences to which the patient is assigned. The randomization list will not be available to any person involved in the conduct of the study or the evaluation of the trial until the trial database is locked. The bioanalytical laboratory staff are authorized to receive the randomization list prior to the study conclusion to determine which samples should be analyzed according to standard operating procedures. As the trial is a crossover design, in which each patient will receive IB1001 and placebo, and serve as their own control, no stratification by age is performed.