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Table 1 Target trial characteristics (information elements)

From: ExaCT: automatic extraction of clinical trial characteristics from journal publications

Element Description
Eligibility criteria logical conditions for being included in the trial, usually split into inclusion and exclusion criteria
Sample size the total number of participants actually enrolled (randomized) in the trial
Start date of enrolment date the enrolment actually started, including day, month, year or as much as presented
End date of enrolment date the enrolment actually ended, including day, month, year or as much as presented
Name of experimental treatment name of experimental intervention
Name of control treatment name of control intervention
Dose dosage of experimental/control intervention
Frequency of treatment frequency of administration of experimental/control intervention
Route of treatment route of administration of experimental/control intervention
Duration of treatment duration of administration of experimental/control intervention
Primary outcome name the outcome(s) of greatest importance, where outcome is a "component of a participant's clinical and functional status after an intervention has been applied, that is used to assess the effectiveness of an intervention" (source: Glossary of Terms in the Cochrane Collaboration)
Primary outcome time point point in time when a primary outcome was assessed
Secondary outcome name outcome(s) used to evaluate additional effects of the intervention deemed a priori as being less important than the primary outcomes (source: Glossary of Terms in the Cochrane Collaboration)
Secondary outcome time point point in time when a secondary outcome was assessed
Funding organization name name of a funding source
Funding number funding grant number
Early stopping whether the trial was stopped earlier
Registration identifier of trial trial registration ID, often ClinicalTrials.gov NCT number
Author name first and last name of the first author
Date of publication year the article was published
DOI digital object identifier for the publication