Detailed statistical analysis plan for ALBINO: effect of Allopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome — a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)

Table 2 Proposed decisions depending on results of the interim analysis of the primary outcome

Result of interim analysis	Resulting new sample size^a	Proposed recommendation
Risk reduction in the experimental group much smaller than expected before the start of the study.	> 780	Immediate discontinuation of recruitment, because sample size cannot be reached with the available resources.
Risk reduction in the experimental group smaller than expected before the start of the study.	> 680–780 (resulting in a prolongation of recruitment of about one year)	Consider to extend recruitment according to the new sample size. No protocol amendment needed due to prolongation of at maximum 1 year.
Risk reduction in the experimental group as expected before the start of the study.	680	Continue to full pre-defined sample size.
Risk reduction in the experimental group higher than expected before the start of the study.	<680	Continue recruitment until actually needed (reduced) sample size is reached.

^aNo. of patients with primary endpoint ascertained to be analyzed for confirmatory analysis (power 80%)

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