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Table 3 Amendments to the original protocol

From: Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial

20 Apr 2015

Original ethics approval (protocol version 1.1)

14 Jul 2015

Amendment 1: (Protocol version 1.2)a

(1) Clarification of the statistical analysis plan in the protocol as suggested by the Independent Data Safety Monitoring Committee

(2) Making the role of funders explicit in the protocol

(3) Including publication plans in the protocol

24 Jun 2016

Amendment 2: (protocol version 3)

(1) Use of telephone consent if parents are not present at the time of admission to the neonatal unit

(2) Inclusion of centres in Bangladesh and Sri Lanka

(3) Sending first birthday cards to the recruited babies

12 Aug 2017

Amendment 3: (Protocol version 3.1)

(1) Discrepancies in the categorisation of moderate and severe disability in the protocol corrected

  1. aAmendment 1 was obtained before recruitment of the first case (16 August 2015)