PASSReviewer 1· 95% conf
The trial design is rigorous with adequate randomization, blinding, power analysis, and prespecified analysis populations.
Evidence
direct quote[Methods, Randomization and masking]
“Patients were randomized centrally using a computer-generated schedule stratified by age group (<60 years, ≥60 years) and location of infarction (anterior, non-anterior).”direct quote[Methods, Randomization and masking]
“Investigators, patients, core laboratory personnel and the sponsor remained blinded until all patients had completed month 6.”paraphrase[Methods, Sample size determination]
“a sample size of 90 patients per group provided 96.0% power to detect a 5-percentage-point difference between 10 mg kg−1 and placebo (step 1) and 84.3% power to detect a 4-percentage-point difference between 5 mg kg−1 and placebo (step 2), within a hierarchical testing procedure.”PASSReviewer 2· 95% conf
The trial design is rigorous with clear randomization, blinding, power analysis, and prespecified analysis populations.
Evidence
direct quote[Methods, Randomization and masking]
“Patients were randomized centrally using a computer-generated schedule stratified by age group (<60 years, ≥60 years) and location of infarction (anterior, non-anterior).”direct quote[Methods, Randomization and masking]
“Investigators, patients, core laboratory personnel and the sponsor remained blinded until all patients had completed month 6.”paraphrase[Methods, Sample size determination]
“a sample size of 90 patients per group provided 96.0% power to detect a 5-percentage-point difference between 10 mg kg−1 and placebo (step 1) and 84.3% power to detect a 4-percentage-point difference between 5 mg kg−1 and placebo (step 2), within a hierarchical testing procedure.”