PASSReviewer 1· 95% conf
The trial design is rigorous with adequate randomization, blinding rationale, power analysis, and inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomisation]
“A statistician with no clinical involvement in the trial prepared sequentially numbered, opaque, sealed envelopes with random permuted blocks (block size known only by the statistician) and no stratifications using a computerised random number generator.”direct quote[Methods, Blinding]
“Blinding of participants and outcome assessors was not possible owing to the nature of the interventions. However, we interpreted the results of the trial according to a blinded data interpretation scheme, to which we made minor refinements.”direct quote[Methods, Statistical analysis]
“Assuming α=0.05, power 80% (1−β=0.8), and accounting for a 20% dropout rate, the required sample size was calculated to be 63 participants in each group (total n=126).”PASSReviewer 2· 95% conf
The trial design is rigorous with adequate randomization, blinding rationale, power analysis, and inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomisation]
“A statistician with no clinical involvement in the trial prepared sequentially numbered, opaque, sealed envelopes with random permuted blocks (block size known only by the statistician) and no stratifications using a computerised random number generator.”direct quote[Methods, Blinding]
“Blinding of participants and outcome assessors was not possible owing to the nature of the interventions. However, we interpreted the results of the trial according to a blinded data interpretation scheme, to which we made minor refinements.”direct quote[Methods, Statistical analysis]
“Assuming α=0.05, power 80% (1−β=0.8), and accounting for a 20% dropout rate, the required sample size was calculated to be 63 participants in each group (total n=126).”