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Patients who had specific circumstances that precluded the use of the above medication optimization paradigm were able to receive review by a cross-site committee of study psychiatrists to determine whether they should be considered effectively optimized.
Guarantors of the article: William J. Sandborn, MD and Stephan R. Targan, MD. Specific author contributions: William J. Sandborn and Stephan R. Targan served on the executive committee of study investigators, and worked with Vera Byers of Immunology Inc., Dean Rutty of Everest Clinical Research Services, Inc., and Tom Tang of Hutchison Medipharma Ltd. to design the study.
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The study was approved by local ethics committees of study sites.
A safety monitoring committee consisting of study endocrinologist, primary care physician and CDE-RNs will be appointed.
Ethical approval was obtained from the research ethics committee of the study center before the initiation of the study (MEC-2015-175).
This study was approved by the ethics committee of Ghent University Hospital (study registration number B67020072708).
The study was approved by the ethics committee of the study center, and all subjects gave written informed consent.
This study was approved from the committee orthodontic department and committee of graduate study and research of the faculty of dentistry Mansoura University in June 2014.
The study protocol was reviewed and approved by the research ethics committee of the study center and relevant regulatory authorities.
The ethics committee of the study institution, in accordance with the World Medical Association Declaration of Helsinki, approved the study.
The study protocol, informed consent and other relevant documents were approved by the independent ethics committee of the study centers.
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