YY participated in the design of the study, did the sample size calculation, generated the random allocation sequence and assigned participants to interventions.
Therefore, not only details of the mechanism used to implement the random allocation sequence are required, but also the steps taken to conceal the sequence, and who generated the random allocation sequence, enrolled and assigned participants are required.
On receipt of a signed preliminary consent form, the coordinator consulted the appropriate allocation sequence list and assigned the participant to the next treatment group number on that list according to the participant's sex, age, and BMI.
Two further independent observers, also blinded to clinical status allocation, confirmed spot counts and assigned results.
The study investigators generated the random allocation sequence, enrolled participants, and assigned participants to interventions.
The physician generated the random allocation sequence, enrolled participants and assigned participants to each groups.
The treatment allocation scheme was generated and assigned by a third party who did not have direct patient contact.
Allocation numbers were generated and assigned to each patient found eligible to be enrolled in the study.
Two independent experimenter (JS, KK) generated the random allocation sequence, enrolled participants, and assigned participants to the intervention groups.
Descriptions of the "method used to implement the randomization sequence" (item 9) and "who generated the allocation sequence and enrolled and assigned participants" (item 10) were the most under-reported, with 214 (71.3%) and 229 (76.3%) trials not meeting these criteria respectively.
