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Based on a review of safety and efficacy data, the study was amended upon completion of randomization to allow additional enrollment into the docetaxel retreatment arm.
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The results implied that the study could potentially be stopped after dose optimization and completion of the first randomization block of Cohort 2. By the time the reestimation step was complete, a total of 27 subjects had been randomized to Cohort 1 (active and placebo, 2 randomization blocks of 12 + 3 additional subjects).
The primary analysis of PFS will compare maintenance pemetrexed to placebo, calculated from the time of randomization following completion of induction treatment to the first date of objectively determined PD or death from any cause.
Serum vitamin D level was assessed at the time of randomization and at completion allowing for stratification of habitual vitamin D intake and assessment of adherence to the treatment plan.
Whole‐blood PUFA levels were assessed at the time of randomization and at completion allowing for stratification of habitual n‐3 LCPUFA intake and assessment of adherence to the treatment plan.
All patients will be assessed at the following time points: baseline (T0), 12 months post-randomization (T1-at completion of intervention), and 24 months post-randomization (T2).
Treatment allocation (randomization) will take place by computer-generated block randomization after completion of baseline questionnaire and IC.
Treatment will commence within 30 days of randomization and following the completion of standard chemotherapy (if given) and concurrently with radiotherapy (if given).
Parents will be notified of group allocation following completion of baseline questionnaires and the randomization process.
The aim at baseline, after completion of all assessments but before randomization, was to give a standard simple explanation of the nature of health anxiety for all participants.
According to the study protocol, DCI data were obtained until the first occurrence of either death, or ICU discharge or the completion of 28 days from study randomization (study treatment period).
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