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All patients were followed up for a total of 28 days from the day of randomization, unless death occurred earlier.
The primary outcome is RTW defined as: "duration of sick leave in calendar days from the day of randomization until full RTW in own or other work with equal earnings, for at least 4 weeks without (partial or full) recurrence.
The primary outcome measure in this study is lasting RTW, defined as: duration of sick leave with CMDs in calendar days from the day of randomization until full RTW in own or other work with equal earnings, for at least 4 weeks without (partial or full) recurrence.
Remission is defined as < 5 points on the PHQ9 [ 43, 44]. 2. The secondary outcome measure is lasting RTW, defined as the duration of sick leave due to MDD in calendar days from the day of randomization until full RTW in own or other work with equal earnings, for at least 4 weeks without (partial or full) recurrence.
Independent predictors of CNP in multivariable analysis, summarised in Table 2, were cardiac failure (RR 2.66, 95% CI 1.11 to 6.40, p = .03), female sex (RR 1.80, 95% CI 1.02 to 3.20, p = .04), the degree of contralateral carotid stenosis, and time to operation of >14 days after the day of randomization (RR 3.33, 95% CI 1.05 to 10.57, p = .04).04
Patients complete questionnaires QLQ-C30/BIL21 QLQ-C30/BIL21of ratdomizathen, andayt 7 days, 28 days, and 90 days after randofization.
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Gallbladder ejection fraction was assessed by investigators or other study site personnel using CCK-HIDA at screening (within 21 days of randomization), on day 1 of cycle 2, day 1 of cycle 6 (±3 days), and at the safety follow-up.
The first treatment session will take place within 7 days of randomization and will be denoted as study day 1.
Study volunteers visited the investigator's site on three separate occasions: day of inclusion, randomization and vaccination (Day 0/Visit 1); Day 10 post-vaccination (Visit 2); Day 28 post-vaccination (Visit 3).
Secondary endpoints were progression-free survival, defined as the time from the date of randomization until the day of documented disease progression or death from any cause, whichever occurred earlier, and response rate.
The date of randomization is denoted as study day 1 for control arm patients.
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