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A randomised, single-blind, controlled clinical trial conforming to CONSORT [ 21] guidelines will be conducted, comparing a multimodal physiotherapy intervention to a physiotherapy education intervention.
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The conduct and reporting of the trial conforms to CONSORT extension guidelines [ 14].
This trial conforms to the Helsinki Declaration and to local legislation.
This trial conformed to good clinical practice guidelines and is registered at NCT00524667.
During the patient's visit to the preoperative outpatient clinic, the anesthesiologist decides whether the patient is eligible for this trial, conform the selection criteria.
Instead, the FDA will accept data from non-IND foreign trials as long as the trial "conforms to the ethical principles contained in the Declaration of Helsinki [ 12]," which contains only very general provisions on ethical review.
The protocol for the clinical trial conformed to the ethical guidelines of the Declaration of Helsinki and the enrolled populations were recruited with ethics committee approved by Xijing Hospital of The Fourth Military Medical University (Xi'an, China).
This trial conformed to the ethical principles for medical research on human beings set out in the declaration of Helsinki and fulfilled the four requirements on research: information, consent, confidentiality and safety of the participant [ 24].
As part of the process of gaining regulatory approval, the project has produced four embryonic stem cell lines deemed good enough to be used in human clinical trials – conforming to the "good manufacturing practice" (GMP) grade.
In all PsA-TT trials, conforming to current practice in clinical development, only 2 grades were used for the assessment of causality: related and unrelated.
All trials conformed to good clinical practice guidelines.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com