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Julious SA, Horspool MJ, Davis S, et al. PLEASANT: Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term – a cluster randomised controlled trial and economic evaluation. Southampton (UK): NIHR Journals Library; 2016 Dec. (Health Technology Assessment, No. 20.93.)

Cover of PLEASANT: Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term – a cluster randomised controlled trial and economic evaluation

PLEASANT: Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term – a cluster randomised controlled trial and economic evaluation.

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Appendix 2Changes to protocol

TABLE 24

Changes to the protocol

Changes to protocolOutcomeResearch ethics committee approval dateApproved by
Protocol version 2 (14 May 2015): this version included an additional secondary outcome to include data up to September 2014, to see if the effect from September 2013 is maintained when there is no study intervention, thus extending the follow-up period by 1 month (see Chapter 2, Changes to the data collection, data extraction and methods for allocation of data after the trial commenced, with reasons)Agreed as a 2-month, non-cost contact variation by the HTA programme on 2 February 201525 May 2014National Research Ethics Service Committee Yorkshire & The Humber – South Yorkshire
Copyright © Queen’s Printer and Controller of HMSO 2016. This work was produced by Julious et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK402195
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