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Written consent was obtained from participants and ethical approval granted from Lothian Research Ethics Committee.
The approval granted from the CPP applies to all sites where the study takes place.
Ethical approval was obtained from the University of Saskatchewan Behavioral Ethics Board and operational approval granted from regional authorities as per their usual protocol.
All participants provided informed written consent under ethical approval granted from local ethics committees (New Zealand AKX/02/00/364; Australia REC 1712/5/2008; London, Leeds, and Manchester 06/MRE01/98; and Cork ECM5(10 05/02/08).
Permission was obtained from Queensland Health PPCS director, and approval granted from the Royal Children's Hospital Human Research Ethics Committee (reference number HREC/03/QRCH/16 AM02) to access the PPCS patient database.
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Ethical approval was granted from The Central Office for Research Ethics Committees COREC and Research Governancece approval was granted from King's College Hospital and Guy's and St Thomas' NHS Foundation Trusts and from Southwark PCT on behalf of Lambeth, Southwark and Lewisham PCT's.
Ethics approval was granted from the Human Research Ethics Committees at the University of Western Australia (approval number = RA/4/1/5202) and Curtin University (HR67/2013).
Approval was granted from the Spectrum Health Institutional Review Board.
Ethical approval was granted from the NT Department of Health and Menzies School of Health Human Research Ethics Committee and the Victorian Department of Justice Ethics Committees.
Ethical approval was granted from Ayrshire and Arran research ethics committee.
Approval was granted from the McLaren IRB/Ethics Review Board for exemption status and the Ministry of Health of Afghanistan.
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