Allocation concealment mechanism
The designing of the randomization sequence within the Redcap tool was performed by a biostatistician who is blinded from the participant enrolment activities. The variables used to design the randomization sequence included gender and age group. At the stage of enrolment, the randomization is conducted in real time on the Internet-enabled Redcap tool by the member of the study team conducting the enrolment. The study team have no control over the randomization sequence.