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Any modifications to the research protocol will be notified to this Human Research Ethics Committee. Informed consent will be obtained from each subject prior to enrollment. The study conforms to the principles of the Declaration of Helsinki and Good Clinical Practice guidelines.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"No personal data will be published, and the informed consent form will include permission to publish group data. 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