Study treatment w ill be permanently discontinued except for a Grade 3 infusion reaction that returns to Grad e 1 in less than 6 hours. Investigators should follow their institutional guidelines for the treatment of anaphylaxis. In case of late-occurring hypersensitivity symp toms (eg, appearance of a localized or generalized pruritus within 1 week after treatment), symptomatic treatment may be given (eg, oral antihistamine or corticosteroids). 7.4 Preparation/Handling/Storage/Accountability The IP should be stored in a secure area according to local regulations.