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The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"NM reports personal fees from Shire and Novartis, outside of the submitted work. All other authors report no conflict of interest.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The dataset will be available to appropriate academic parties on request from the Chief Investigator (LCC) in accordance with the data sharing policies of King's College London and the National Perinatal Epidemiology Unit Clinical Trials Unit, with input from the co-investigator group where applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"The trial was approved by the South Central-Hampshire B Research Ethics Committee (no13\/SC\/0645).","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"LCC, RH, EJ, PH, NM and AS were involved in the study conception and in securing funding for the study. LCC and AS were co-chief investigators responsible for all aspects of the study. RH did the health economic analysis with input from MG and LL on the statistical component. LCC, EJ and NM provided advice on the analysis. AP made a substantial contribution to the running of the trial. RH, ABG and LCC wrote the article. All authors reviewed, contributed to, and approved the final version of the manuscript.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}}]}}