PASSReviewer 1· 90% conf
The trial design is rigorous with adequate randomization, blinding, power analysis, and pre-specified endpoints, though some details on inclusion/exclusion and outlier handling are limited.
Evidence
direct quote[Methods, Study procedures]
“Randomization was performed by using a permuted block design using an interactive web response system and was stratified by (1) presence of atrial fibrillation or atrial flutter on screening electrocardiogram and (2) region of enrollment.”direct quote[Methods, Study procedures]
“eligible patients were randomized double blind (1:1:1:1) to receive volenrelaxin 25 mg, volenrelaxin 50 mg or volenrelaxin 100 mg per week or placebo subcutaneously”direct quote[Methods, Statistical methods]
“Assuming an s.d. in LA reservoir strain of 8.5% and a two-sided α level of 0.05, 91 completers for 50-mg, 100-mg and placebo groups was calculated to provide 88% power to detect a treatment difference of 4% or more for the primary endpoint.”PASSReviewer 2· 90% conf
The trial design is rigorous with adequate randomization, blinding, power analysis, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Study procedures]
“Randomization was performed by using a permuted block design using an interactive web response system and was stratified by (1) presence of atrial fibrillation or atrial flutter on screening electrocardiogram and (2) region of enrollment.”direct quote[Methods, Study procedures]
“eligible patients were randomized double blind (1:1:1:1) to receive volenrelaxin 25 mg, volenrelaxin 50 mg or volenrelaxin 100 mg per week or placebo subcutaneously”direct quote[Methods, Statistical methods]
“Assuming an s.d. in LA reservoir strain of 8.5% and a two-sided α level of 0.05, 91 completers for 50-mg, 100-mg and placebo groups was calculated to provide 88% power to detect a treatment difference of 4% or more for the primary endpoint.”