PASSReviewer 1· 95% conf
The trial design is rigorous with clear randomization, blinding, power analysis, and pre-specified endpoints.
Evidence
direct quote[Methods, Study participants]
“Randomization was completed via an electronic data capture system, where randomization was blocked and stratified by site and by enrollment in a neurological substudy.”direct quote[Methods, Study participants]
“Randomized patients were blinded to their procedural assignment.”paraphrase[Methods, Statistical analysis]
“To achieve power greater than 80% for testing each primary endpoint using the Farrington–Manning method, a sample size of 350 evaluable patients (175 per arm) was required for the primary analysis cohort.”PASSReviewer 2· 95% conf
The trial design is rigorous with clear randomization, blinding, power analysis, and pre-specified endpoints.
Evidence
direct quote[Methods, Study participants]
“Randomization was completed via an electronic data capture system, where randomization was blocked and stratified by site and by enrollment in a neurological substudy.”direct quote[Methods, Study participants]
“Randomized patients were blinded to their procedural assignment.”paraphrase[Methods, Statistical analysis]
“To achieve power greater than 80% for testing each primary endpoint using the Farrington–Manning method, a sample size of 350 evaluable patients (175 per arm) was required for the primary analysis cohort.”