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Article History

Received: 9 July 2018

Accepted: 4 December 2018

First Online: 5 January 2019

Ethics approval and consent to participate

: The MCLASS II trial has been granted ethics approval by the National Research Ethics Committee of the Bangladesh Medical Research Council (Ref: BMBC/NREC/2016–2019/358) and the Health Sciences Research Governance Committee at the University of York (no reference number, approval date 8 August 2017). Any protocol amendments will be submitted to the two ethics committees for approval.Written consent will be obtained by FIs from all those who are eligible and after having received study information (in Bangla) and sufficient time (24 h) to consider, are willing to participate. All participants will be provided with the relevant patient information sheet prior to their giving consent. The information sheet will outline fully the potential benefits and risks of being involved in the relevant part of the study. The information sheets will meet all the requirements of the local Ethics Committees in Bangladesh. Household heads/leads will explicitly be asked to consent for the installation of Dylos meters in their homes. Illiteracy is an issue in this study setting, which could be an impediment to obtaining informed consent. However, the research teams are trained in explaining research information using local dialect and pictorial participant information sheets. Those unable to sign can provide a thumb print impression on the consent form, an acceptable alternative to signature in Bangladesh.In line with the Data Protection Act and the Research Governance Framework, all data collected will be confidential, being identified with the unique study identification number only – assigned at the beginning of the study. Access to the participants’ personal detail will be restricted to the necessary members of the research team only. Monitors and auditors may also need to access the data. Encrypted data transfer from the ARK Foundation to the University of York will be via secure drop-off services available through the University of York. At the end of the study, hard copies of data will be securely archived at the ARK Foundation in Dhaka, Bangladesh, whilst the digital database will be securely archived by the University of York, for a minimum of 5 years.

: Not applicable.

: The authors declare that they have no competing interests.

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