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Donors will subsequently sign the informed consent in case of study participation.
In case of study discontinuation, all observations and tests except for MacCAT-CR will be performed.
In case of study discontinuation data will be extinguished, except the patient affirms explicitly the further analysis of his data.
This allows to analyze data from an effectiveness (outcome in real life circumstances, using all data, including imputed data in case of study drop-out etc).
In case of study exit, attempts will be made to obtain at least vital status and dates of unplanned cardiovascular hospitalizations.
In case of study discontinuation, all material will be destroyed or the patient will be asked if he/she accepts that the existing material can be used for the study.
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All participants are allowed to contact the U-TURN study nurse by phone in case of study-related questions (eg, pharmacological treatment, sports injuries, etc).
This implies that measurements should possibly be performed by the same investigator in case of studies or repeated measurements.
In case of studies with longitudinal design, most have their last assessment within 1 year post-disaster.
In case of studying 24 h adverse reactions, the dose was adjusted based on the average toxicity and the last tolerated dose for the new group of mice.
We will electronically search the following databases: MEDLINE, CINAHL, PEDro and ScienceDirect, without any language restrictions (in case of studies in a language other than English, we will contact companies specialised in translation).
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CEO of Professional Science Editing for Scientists @ prosciediting.com