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The ethics committee, Research and Development (R & D), and the trial steering and data monitoring committees approved this change (in June 2013) before any outcome data were formally examined.
It might if you were to read it casually read "before any outcome data were examined", whereas the two are about as far apart as could possibly be.
I would assume without checking that the ethics committee involved had a significant number of the PIs in this trial, and PACE-related ones, as well as camp-followers.
Also - how can the 12 month results be unavailable, hasn't it been considerably more than 12 months since the study ended?
One wonders on FOIA.