Table 5 Randomization, blinding, and statistical methods

 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