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Surveillance methods, study protocols, and results of EIP work have had effects around the world.
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This paper describes the design, methods, study protocol, and regulatory implementation processes for a multi-site randomized controlled trial that aims to evaluate the effectiveness of a caring emails intervention for suicide prevention in the military and VA healthcare systems.
Ethical approval was granted for the full mixed-methods study protocol under a single application to St Thomas' Hospital Research Ethics Committee (approval ref 05/Q0702/5).
For example, its 'target nutrients' project is aimed at developing methods and study protocols that can be used by industry to substantiate specific structure/function claims of the positive effects of nutrients and nutraceuticals on cognitive and mental function and dermal condition.
Patients and methods The study protocol was approved by an ethics committee and informed consent was obtained from all patients.
There were no changes made to either methods or study protocol after trial registration.
NS, JA, SW and PR devised the methods and study protocol.
Methods: This study protocol describes the AHP in five sequential steps using a small group of diabetes experts representing various clinical disciplines.
Methods: This study protocol describes the planned design and analyses of an individual participant data meta-analysis, to examine whether job strain is associated with an increased risk of clinically diagnosed unipolar depression based on hospital treatment registers.
Additional details of the sampling method and study protocol are described elsewhere (Lacey et al. 2009).
Pilot studies, study protocols, methods papers, and studies using quasi-randomized designs were excluded, as well as articles reporting secondary results of a trial with main results published elsewhere.
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