PASSReviewer 1· 95% conf
The trial design is rigorous with adequate randomization, blinding, power analysis, and pre-specified populations.
Evidence
direct quote[Methods, Randomization and Treatment]
“An interactive-response system was used for randomization with a central computer-generated sequence and a block size of 6.”direct quote[Methods, Randomization and Treatment]
“The trial sponsor, investigators, site staff members who were participating in patient care or clinical evaluations, and patients were not aware of treatment assignments.”paraphrase[Methods, Statistical Analysis]
“We determined that the enrollment of at least 396 patients in the microITT population would provide the trial with more than 90% power for the assessment of the primary outcome.”PASSReviewer 2· 95% conf
The trial design is rigorous with adequate randomization, blinding, power analysis, and pre-specified populations.
Evidence
paraphrase[Methods, Randomization and Treatment]
“An interactive-response system was used for randomization with a central computer-generated sequence and a block size of 6. Randomization was stratified according to infection type (complicated UTI or acute pyelonephritis only) and region (North America and Western Europe, Eastern Europe, or rest of the world).”direct quote[Methods, Randomization and Treatment]
“The trial sponsor, investigators, site staff members who were participating in patient care or clinical evaluations, and patients were not aware of treatment assignments.”paraphrase[Methods, Statistical Analysis]
“We determined that the enrollment of at least 396 patients in the microITT population would provide the trial with more than 90% power for the assessment of the primary outcome, assuming that 75% of the patients in the two treatment groups had composite success.”