Ethics Committee Approval: Authors declared that the research was conducted according to the principles of the World Medical Association Declaration of Helsinki
"Ethical Principles for Medical Research Involving Human Subjects", (amended in October 2013).
World Medical Association Declaration of Helsinki
: ethical principles for medical research involving human subjects.
Informed Consent: This work has been conducted with the informed and overt parental consent, in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki
) and the standards established by the local Institutional Review Board.
In the year 2008, the "World Medical Association" incorporated a new article under the heading of "Research registration and publication and dissemination of results" in the "Declaration of Helsinki
" stating that "Every clinical trial must be registered in a publicly accessible registry prior to the recruitment of the first participant in the study".4,8 In 2010 CONSORT guidelines for trial reporting also added trial registration item in guidelines for transparent reporting of trials.9 With the passage of time, more and more journals endorsed clinical trial registration, resulting in a rapid increase in registered trials10 and recently trial registration has been marked as single most valuable way to ascertain unbiased research reporting.11
The Declaration of Helsinki
has been recognised as one of the most authoritative statements on ethical standards for human research in the world.
The study was conducted under ethical principles from the Declaration of Helsinki
and national laws.
The study was conducted in accordance with the ethical standards of the Declaration of Helsinki
of 1964, as revised in 2013.
Multinational companies must abide by international standards such as the World Medical Association's (WMA) Declaration of Helsinki
. The researchers gave particular attention to post-trial access to services and medicines.
The study protocol conformed to the ethical guidelines of the Declaration of Helsinki
from 1975 as revised in 1983.
The declaration of Helsinki
states that every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.
The research study was performed with reference to the principles of the Declaration of Helsinki
. (15) Ethical approval was granted by the Research Ethics Committee, Kowloon West Cluster, Hospital Authority of Hong Kong.
The trial was performed in accordance with the declaration of Helsinki
and its subsequent revisions.