PASSReviewer 1· 95% conf
The trial design is rigorous with adequate randomisation, blinding of researchers, power analysis, and pre-specified analyses.
Evidence
direct quote[Methods, Randomisation and blinding]
“We used Nettskjema, an independent web based survey tool, to randomise participants using a computer generated pseudorandom sequence over which we had no influence.”direct quote[Methods, Randomisation and blinding]
“The researchers and study statistician were blinded to intervention allocation throughout the trial, and all main analyses were performed blinded.”direct quote[Methods, Statistical analysis]
“We calculated that a minimum of 2692 participants (1346 in each arm) would be required to detect a risk reduction of 30% from an assumed 10% risk of infection in the control arm to a 7% risk in the intervention arm, with a two sided α of 0.05 (significance criterion) and 80% power.”PASSReviewer 2· 95% conf
The trial design is rigorous with adequate randomisation, blinding of researchers, a priori power calculation, and pre-specified analyses.
Evidence
direct quote[Methods, Randomisation and blinding]
“We used Nettskjema, an independent web based survey tool, to randomise participants using a computer generated pseudorandom sequence over which we had no influence.”direct quote[Methods, Randomisation and blinding]
“The researchers and study statistician were blinded to intervention allocation throughout the trial, and all main analyses were performed blinded.”direct quote[Methods, Statistical analysis]
“We calculated that a minimum of 2692 participants (1346 in each arm) would be required to detect a risk reduction of 30% from an assumed 10% risk of infection in the control arm to a 7% risk in the intervention arm, with a two sided α of 0.05 (significance criterion) and 80% power.”