Plans to promote participant retention and complete follow-up {18b}
Follow-up will take place in a hospital and should be minimal, so there is no need for strategies to increase retention. A woman can withdraw from the trial at any time. She may give her reason for withdrawal but she does not have to. If a woman withdraws from the trial, we will analyse data collected to the point of withdrawal, but no other data will be collected unless the woman gives permission. In all cases, we will respect the woman’s wishes. At discharge, women will be given an ‘alert card’ identifying them as an I’M WOMAN trial participant and asked to present this card to anyone providing medical care after discharge, up to day 42. The card will have instructions to ensure the AE reporting procedures are followed.