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Table 5 Randomization, blinding, and statistical methods

From: Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection

 Sequence generation Patient-level, permuted block design
Stratified by center, race, age
Randomized equally to each study arm
 Allocation concealment Central Web-based randomization, accessible 24 h/day
 Implementation Local center staff enroll patients via Web-based randomization system
Web-based system then assigns patients to trial arm, based on computer generated allocation sequence
Blinding Statistical analysis and post-discharge outcome assessment staff are blinded to study arm
By arm outcome data restricted to unblinded statistician and data safety monitoring board
Statistical methods Intention-to-treat, as per pre-established analysis plan (primary analysis)
Per-protocol analysis, where procalcitonin guideline is followed