HIGHLIGHTS
- who: Othman Al-Sawaf from the Study design and participants This phase, randomized, open-label, parallel-group registrational study was conducted at , sites in , countries (Supplementary Table, )The study was approved by the Central Ethics Committee of the University of Cologne, Germany. Patients were enrolled between , August , and , August, . The study was registered at US and EU clinical trial registries (NCT02242942, EudraCT, ) and approved by ethical review boards responsible for each study site. The study was performed according to the principles of the Declaration of Helsinki. All patients provided written informed consent to participate. The study protocol . . .
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