Randomization and blinding
SEPARATION
The random allocation sequence was generated with computer-generated random numbers by the study statistician, and sequentially numbered opaque envelopes containing the treatment allocation were utilized to conceal the sequence. Participants will be randomly assigned 1:1 to dapagliflozin (10 mg once a day) or matched placebo with blocked randomization of 10 patients in each block to ensure balance in the treatment groups in case the study needs to be stopped early. Patients and all study personnel (except the independent study statistician) will be kept blinded to the treatment allocation. The trial will adhere to established procedures to maintain separation between the staff that performs the outcome measurements and the staff that delivers the intervention. Staff members who obtain the outcome measurements will not be informed of the treatment group assignment. The intervention staff members who deliver the intervention will not perform the outcome measurements. The dapagliflozin and placebo are packaged in an identical manner with the same labelling, tablet appearance and schedule.