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CONSORT diagram of the NOHARM trial. A total of 199 young children with sickle cell anemia (SCA) completed Year 1, either fixed-dose hydroxyurea or placebo treatment. All but one then entered the open-label treatment phase and 192 completed the study after Year 2 of hydroxyurea treatment. There were five deaths in the open-label treatment phase; including two (*) that occurred within the scheduled 30-day window after the final end-of-study visit.
