Created at Source Raw Value Validated value
Dec. 15, 2020, 1:30 a.m. eu

1.Demonstrated or suspected uncontrolled systemic severe infection, such as sepsis (e.g.: positive blood culture, or procalcitonin ≥0.25 μg/L) 2.Demonstrated local extrapulmonary abscess 3.Chemotherapy for less than 3 months 4.Use of other investigational drug within 4 weeks or a period of 5 half-lives duration prior to Day1 (whichever is longer) 5.Ongoing participation in any other therapeutic clinical trial XML File Identifier: UMHQJ2DEWA4np0qWjAkTqsbNM4k= Page 8/15 01/08/2020 6.Hypersensitivity to the active substance or any of the ingredients of the IMP or placebo 7.Pregnancy 8.Age <18.

1.Demonstrated or suspected uncontrolled systemic severe infection, such as sepsis (e.g.: positive blood culture, or procalcitonin ≥0.25 μg/L) 2.Demonstrated local extrapulmonary abscess 3.Chemotherapy for less than 3 months 4.Use of other investigational drug within 4 weeks or a period of 5 half-lives duration prior to Day1 (whichever is longer) 5.Ongoing participation in any other therapeutic clinical trial XML File Identifier: UMHQJ2DEWA4np0qWjAkTqsbNM4k= Page 8/15 01/08/2020 6.Hypersensitivity to the active substance or any of the ingredients of the IMP or placebo 7.Pregnancy 8.Age <18.