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The minimum enrolment sample size will include 150 surgical patients, 200 patients receiving intensive medical therapy and 150 patients wait-listed to enter the clinic.
One male participant from the home arm died after the enrolment interview and was replaced bringing the total enrolment sample to 41.
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Based on several enrolment samples, independent component analysis and k-means clustering is employed to extract 16 coefficients from most stable parts of the iris textures.
We performed PA strain typing on retrospectively collected enrolment samples and recent isolates to identify patients infected with ePA.
To achieve a sample size of 100 cases and 100 controls and to account for refusals and for exclusions after enrolment, sampling foresaw contacting 300 cases and 600 controls.
This will consists of all clinicians - neonatologists and/or pediatric intensivists - working in intensive care units (at the University Hospital " A.Gemelli" or in so called "Collaborating centers") where patients' enrolment, samples and data collection will be performed.
Written informed consent was obtained from all patients and controls before enrolment or sample withdrawal.
All the participants gave written informed consent prior to enrolment and sample collection.
For any studies where insufficient detail is given to determine eligibility (eg, minimum age of enrolment or sample size), we will contact the corresponding author by email (without a reminder) to seek clarification.
To achieve adequate participant enrolment to sample size, each site can recruit through either primary or secondary care pathways, with each site having the opportunity to implement secondary strategies depending on recruitment performance which will be formally reviewed periodically by the central trial management team.
Following enrolment, blood samples were taken pre-operatively, and further samples were collected at day one and day seven post-operatively.
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