Hunter, Rachael http://orcid.org/0000-0002-7447-8934
Beardmore-Gray, Alice
Greenland, Melanie
Linsell, Louise
Juszczak, Edmund
Hardy, Pollyanna
Placzek, Anna
Shennan, Andrew
Marlow, Neil
Chappell, Lucy C.
,
Funding for this research was provided by:
Health Technology Assessment Programme (12/25/03)
Article History
Accepted: 7 July 2022
First Online: 21 July 2022
Declarations
:
: This paper presents independent research commissioned by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project reference 12/25/03). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
: NM reports personal fees from Shire and Novartis, outside of the submitted work. All other authors report no conflict of interest.
: 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.
: The trial was approved by the South Central-Hampshire B Research Ethics Committee (no13/SC/0645).
: 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.
: Informed consent was obtained from all individual participants included in the study.
: Not applicable.
: Not applicable.