Study design and inclusion and exclusion criteria
The STREAM trial was an academic, multicenter, single-arm, two-stage, phase II study conducted at four centers in Italy.Eligible patients had a confirmed diagnosis of All patients provided written informed consent. The study was conducted following the principles of the Declaration of Helsinki and the International Conference on Harmonization and Good Clinical Practice guidelines. Ethics Committees of the participating centers approved the study protocol (EudraCT Number: 2015-001105-13; available online as 