Table 2

Assessment of validity of the analysed studies according to the CONSORT checklist18

Section/ topic	Item number	Neri et al 14	Sakuramoto et al 15	Fujimoto et al 16	Douglass et al 17
Title and abstract
	1a	Yes	No	No	No
	1b	No	Yes	No	No
Introduction
Background and objectives	2a	Yes	Yes	Yes	Yes
	2b	Yes	Yes	Yes	Yes
Methods
Trial design	3a	No	Yes	No	No
	3b	Not applicable	Yes	No	No
Participants	4a	Yes	Yes	Yes	Yes
	4b	Yes	Yes	No	No
Interventions	5	Yes	Yes	Yes	Yes
Outcomes	6a	Yes	Yes	Yes	Yes
	6b	Not applicable	Not applicable	Not applicable	Not applicable
Sample size	7a	No	Yes	No	No
	7b	No	Yes	Not applicable	Not applicable
Randomisation	8a	No	Yes	No	No
	8b	No	No	No	No
	9	No	No	No	No
	10	No	No	No	No
Blinding	11a	No	No	No	No
	11b	Yes	Yes	No	Yes
Statistical methods	12a	Yes	Yes	No	Yes
	12b	Not applicable	Not applicable	No	No
Results
Participant flow	13a	No	Yes	No	No
	13b	No. Same as 13a	Yes	No	No
Recruitment	14a	Yes (previous publication)	Yes	No	Yes
	14b	No	Yes	No	No
Baseline data	15	Yes	Yes	No	Yes
Numbers analysed	16	No	Yes	No	No
Outcomes and estimation	17a	Yes	Yes	No	Yes
	17b	Not applicable	Yes	Yes	Not applicable
Ancillary analysis	18	Not applicable	Yes	No	No
Harms	19	No	Yes	Yes	Yes
Discussion
Limitations	20	No	No	No	Yes
Generalisability	21	No	Yes	No	No
Interpretation	22	Yes	Yes	Yes	Yes
Other information
Registration	23	No	Yes	No	No
Protocol	24	No	No	No	No
Funding	25	No	No	No	No

CONSORT, Consolidated Standards of Reporting Trials.