As per protocol, a Futility Analysis was scheduled after 50 patients (33% of the 150 planned patients) have completed the Induction Phase (availability of the primary endpoint at Week 10). To be consistent with the main purpose of a futility analysis (i.e. to unnecessarily expose patients to an investigational drug in a study that will not be able to show a treatment effect in its end), enrollment has been placed on hold starting 01 Dec 2021. Following the futility analysis, OSE accepted the IDMC recommendation to continue the study with modifications to the design (including testing one OSE-127 dose instead of 2). This recommendation automatically prolonged the enrollment hold period pending the regulatory acceptance of the protocol amendment. The induced additional delays in enrollment ended up in return in a foreseen lack of availability of vials with acceptable expiration period and had, as a consequence, the need for production of a new study medication batch, which also induced a prolongation of the enrollment hold period including for the regulatory part. Those unexpected circumstances did not affect the benefit/risk ratio nor the continuation of clinical trial activities for patients already enrolled. Enrollment resumed on 19 Sep 2022.