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. 2018 Dec 22;9(6):1047–1056. doi: 10.1093/tbm/iby131

Table 4.

| Randomization reporting checklist for factorial trials

Item number Checklist item
1 Randomization unit: components or conditions and rationale for this choice
1b If components: randomization conducted sequentially or independently and rationale for this choice
2 Method used or planned to be used to generate the random allocation sequence
3 Type of randomization; details of any restriction
4 Mechanism used or planned to be used to implement the random allocation sequence, describing any steps to conceal the sequence until interventions were assigned
5 Who generated or will generate the random allocation sequence, who enrolled or will enroll participants, and who assigned or will assign participants to interventions
6 (Protocola and results papers) Additional details about actual implementation, such as unforeseen challenges.
7 (Protocola and results papers) Final sample sizes in each condition

Items 2–5 are from the CONSORT 2010 statement for reporting of two-arm parallel randomized trials and the SPIRIT 2013 statement for the reporting of trial protocols [32, 34].

aIf data are available at time of publication of protocol paper.