Who will take informed consent? {26a}
If women can give fully informed consent, then information about the trial will be given and written consent will be obtained. An overview of the consent procedure is provided in Additional file First, a member of the site trial team will identify a potentially eligible woman and then approach the woman with the agreement of the primary carer. She will be given information about the trial (Additional file If the woman withdraws a previously given informed consent, data collected to the point of withdrawal of consent will be used as part of the analysis.