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B 16, 602610

doi: 10.1034/j.1601-183X.2003.00037.x 9 NicoliniCFahnestockM

A consecutive sampling method was used to select participants

Analysis of effectiveness of treatment (main outcome) at the three monitoring points Intention-to-treat and per-protocol analyses will both be performed, as is recommended for non-inferiority studies [38]