Randomisation Was the allocation sequence adequately generated? Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups	Tick one row	Relevant supporting text and location (page/column/paragraph)
Yes: for example, a computer-generated random sequence or a table of random numbers
No: for example, non-randomised or quasirandomised (participants allocated on basis of date of birth, clinic identification number or surname)
Unclear: Insufficient information about the sequence generation
ALLOCATION CONCEALMENT Was the randomisation sequence for allocating participants to the different arms of the trial adequately concealed, to prevent both participants the clinicians providing treatment predicting in advance which arm of the trial a women would be assigned to?
Yes: for example, where the allocation sequence could not be foretold
No: for example, open random number lists or quasi randomisation such as alternate days, odd/even date of birth or hospital number
Unclear: for example, if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque and sealed
BLINDING OF OUTCOME ASSESSORS: Were the clinicians who assessed disease progression at the end of follow-up prevented from knowing which arm of the trial the women were assigned to?
Yes: outcome assessors were blinded
No: no blinding or incomplete blinding of outcome assessors
Unclear: insufficient information to permit judgement of ‘yes’ or ‘no’