| Generation of allocation schedule: Did the author(s) use: |
| Random‐number tables? Yes/No |
| Computer random‐number generator? Yes/No |
| Coin tossing? Yes/No |
| Shuffling of allocation cards? Yes/No |
| Any other method that appeared random? Yes/No (if yes, please specify) |
| Concealment of treatment allocation: Which of the following was carried out? |
| There was some form of centralized randomization scheme where details of an enrolled participant were passed to a trial office or a pharmacy to receive the treatment group allocation. Yes/No |
| Treatment allocation was assigned by means of an on‐site computer using a locked file that could be accessed only after inputting the details of the participant. Yes/No |
| There was numbered or coded, identical‐looking preparation of drugs, which were administered sequentially to enrolled participants. Yes/No |
| There were opaque envelopes which had been sealed and serially numbered utilized to assign participants to intervention(s). Yes/No |
| A mixture of the above approaches including innovative schemes, provided the method appears impervious to allocation bias. Yes/No |
| Allocation by alternation or date of birth or case record or day of the week or presenting order or enrollment order. Yes/No |
| Exclusion of allocated participants from the analysis of the trial: |
| Did the report mention explicitly the exclusion of allocated participants from the analysis of trial results? Yes/No |
| If so, did the report mention the reason(s) for exclusion? Yes/No (if yes, please specify) |
| Measures to implement double‐blinding: |
| Did the report mention explicitly measures to implement and protect double‐blinding? Yes/No (if yes, please specify) |
