Study design and patients
ICH
IKEMA was a prospective, randomized, open-label, active-controlled, Phase 3 study (NCT03275285) conducted worldwide, at 69 study centers in 16 countries. Study eligibility and exclusion criteria have been described in detail previously [The study protocol was approved by the Institutional Ethics Committee or independent review board at each center. The study was conducted following the Declaration of Helsinki and the International Council for Harmonisation (ICH) Guidelines for Good Clinical Practice. All patients provided written informed consent.