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This study is in compliance with all federal guidelines governing studies of human participants.
For epidemiologic studies, consideration would need to be given to ethical issues governing studies of human subjects.
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This difference was a feature of two variables: the first was the different doses on which patients were maintained by their physicians before enrolling into the study and the second was a dose adjustment to ensure equivalent AUC in accordance with local regulations governing study design [19,25].
No regulations govern study abroad programs, except a voluntary code of ethics from an industry trade group that limits members to "gifts that are of nominal value and that do not seem intended to influence professional decisions".
The rules that govern study enrollment end up creating trial populations that invariably are much younger, have fewer health complications and have been exposed to far less medical treatment than those who are likely to use the drug.
Notification of the study was also sent to the ethics committees of each participating center, as required by Italian regulations governing observational studies (AIFA document, dated 30 March 2008).
Some of Midwest Heart's research has also fallen short of federal rules governing clinical studies.
All experiments were performed in accordance with the German legislation governing animal studies following the Principles of Laboratory Animal Care National Institutes of Healthh publication 85-23, revised 1996 [21]).
All animal experiments were classified as grade zero, which implies minimal suffering of mice and the 3R principles were strictly implemented as required by the Swiss laws governing experimental studies involving animals.
The amended Act changes the rules governing (drug) studies in The Netherlands.
All experiments were performed in accordance with the German legislation governing animal studies following The Principles of Laboratory Animal Care [ 14].
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