LOW RISK The investigators describe a random component in the sequence generation process such as: • Referring to a random number table • Using a computer random number generator • Coin tossing • Shuffling cards or envelopes • Throwing dice • Drawing of lots/slips

HIGH RISK The investigators describe a non‐random component in the sequence generation process. Usually, the description would involve some systematic, non‐random approach, for example: • Sequence generated by odd or even date of birth • Sequence generated by some rule based on date (or day) of admission • Sequence generated by some rule based on hospital or clinic record number. • Allocation by judgement of the clinician • Allocation by preference of the participant • Allocation based on the results of a laboratory test or a series of tests • Allocation by availability of the intervention

UNCLEAR RISK Insufficient information about the sequence generation process to permit judgement of ‘Yes’ or ‘No’.