It means a non-randomised trial.
The optimal way is to have 2 (or more) study arms with patients evenly randomised. One receiving the drug, the other placebo.
Then you can compare the results between the groups.
the 001 trial did not do this as (in Kurtzbergs words), they were unwilling to subject children to placebo (i.e. no treatment)
Ryoncil: ODAC/FDA Meeting Discussion, page-1062
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