Charts with no baseline information on the intake form, especially demographic data, and chart numbers that could not be found during random sampling were replaced by the next study subject (number) in the list of the study population.
In this study subject number is fifty-two patients with mild-to-severe dementia (Alzheimer's disease, 30; vascular dementia, 9; Alzheimer's disease with CVD; dementia with Lewy bodies, 10).
If a subject discontinued from the study, the subject number was not reused, and the subject was not allowed to re-enter the study.
Upon consent to participate, subjects are assigned a study number which will identify their data.
Study population: age, sex, neuroblastoma at first diagnosis or at recurrence, stage, inclusion and exclusion criteria, number of subjects (including number eligible for the study, number enrolled in the study, number subjected to the index test and reference standard, number for whom results were reported in the two-by-two-table, reasons for withdrawal).
Subjects were automatically allocated a study number by the database system on recruitment.
At recruitment, a subject is given a unique study number.
Each site maintained a Microsoft® Excel file that linked each subject's study number in the EDC to the subject's original medical record number to allow local access to electronic data and medical records as needed.
The investigator in each participating hospital will maintain a list in which the correspondence between the true identity of the subject and its study number is documented.
The first two digits specified the school and the next 3 digits the subject's individual study number based on the sequence of their recruitment.
