Avid Bioservices Inc (CDMO)

[Protector]

BioBS2012,

The time of randomization would be the moment one is assigned to an arm (Control arm SOC+Placebo or Investigational arm SOC+Bav 3mg/kg).

That means the patients was BEFORE THAT:
- found fit to participate (match the criteria)
- enrolled in a centre

We must assume that when the patient is then assigned to an arm by randomization they do start treating him immediately because his time runs.

So at first glance I would say there shouldn't be much of a difference in the tables because that description would fit "start of treatment".