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Exact(5)
These characteristics were similar to those of the main trial including 91 patients [ 19].
Data were collected in 2006 at the 24-month follow-up of the main trial, including behavioral and laboratory data.
21 The methods for the main trial, including participant inclusion and exclusion criteria, the nature of the randomisation procedure and retention rate are all described in detail separately.
We will use a number of biomedical outcomes in the main trial including body composition (MRI), and biochemical risk markers (lipids, inflammatory markers, glucose).
In Finland the pilot for a non-blind, patient-managed trial on hormone therapy (HT) revealed several obstacles to the main trial, including the difficulty to discontinue HT and a negative attitude among Finnish physicians towards the trial [ 5].
Similar(55)
Secondary hypotheses for the main trial include: "Education for primary care teams in problem focused therapy for patients presenting to primary care with insomnia improves daytime sleepiness, anxiety and depression, health-related quality of life and reduces hypnotic use, adverse effects and costs compared to treatment as usual including sleep hygiene".
To assess the feasibility of the main trial methodology including the use of a screening tool, subject recruitment and retention, and data collection procedures including economic evaluation to inform the future design of a definitive randomised controlled trial.
Double data entry was carried out for the key variables relating to the main trial outcomes, including randomisation criteria, all anthropometric and biomedical measures and demographic and health economics data.
In this table we report the main results of the original trial including all patients, and results including only those patients, (209 in the dalteparin group and 239 in the unfractionated heparin group), who were not co-enrolled in another randomized trial (1,664 in the dalteparin arm and 1,633 in the unfractionated heparin arm).
The current paper provides a comprehensive synopsis for the main design of the MedLey trial, including ethics approval, participant recruitment, screening and selection, randomisation, study procedure, safety considerations, and focuses on the rationale and methodology for the cognitive outcomes of interest.
Data were extracted from studies included in the review onto a standard proforma (see Additional file 1) in three main categories: basic information about the trial (including epidemiology, intervention and trial size), reasons for using a stepped wedge design and methods of data analysis.
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