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. 2021 Jul 28;11(7):e050755. doi: 10.1136/bmjopen-2021-050755

Table 2.

Summary of ethical amendments

Protocol Date Summary of changes
V3 24.05.2018 Funding and approval secured to expand the study to allow multicentre recruitment and NIHR portfolio adoption
V4.1 15.10.2018 Additional exclusion criteria added:
  1. Mirena coil in situ or removed within the last 3 months.

  2. Any other condition that would compromise participant safety or data integrity.

V4.3 06.03.2020 Approval to allow recruitment strategy to include proven endometrial cancer cases prior to hysterectomy
V4.4 16.07.2020 Approval to allow remote consent and data collection, if required, as part of COVID-19 safety mitigation measures

NIHR, National Institute for Health Research.