Central reading process is performed as blinded independent image review of each case by two readers as primary readers. These two primary readers must be completely unaware of the findings of each other, including review outcomes of other blinded reader, an adjudicator, and onsite investigators.

  When one or more overall time point assessment(s) differs between these two primary readers, it will be re-assessed by a third reader as an adjudicator. At this point, the adjudicator should agree with all-time point assessments from only one of the primary readers.