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. 2023 Mar 20;12(6):2401. doi: 10.3390/jcm12062401

Table A1.

Risk of bias assessment of randomized clinical trials according to RoB2 tool.

Study Randomization Process Deviation from Intended Interventions Missing Outcome Data Measurement of Outcome Selection of Reported Result Overall
Kokudo et al., 2021 [34] 1.2 Y, 1.1 Y, 1.3 N
LR
Part1: 2.1/2.2 Y, 2.3 PY, 2.4 PN
SC
Part2: 2.6Y
LR
3.1 Y
LR
4.1 N, 4.2 N, 4.3 Y, 4.4 PN
LR
5.2/5.3 N 5.1 Y
LR
SC
Kanemitsu et al., 2021 [33] 1.2 Y, 1.1 Y/PY, 1.3 N/PN
LR
Part1: 2.1/2.2 Y, 2.3 PY, 2.4 PN
SC
Part2: 2.6Y
LR
3.1 Y
LR
4.1 N, 4.2 N, 4.3 Y, 4.4 PN
LR
5.2/5.3 N 5.1 Y
LR
SC
Kemeny et al., 2011 [43] 1.2 NI, 1.3 PN
SC
Part1: 2.1/2.2 NI, 2.3 N
LR
Part2: 2.6 Y
LR
3.1 Y
LR
4.1 N, 4.2 N, 4.3 Y, 4.4 PN
LR
5.2/5.3 N 5.1 Y
LR
SC
Ychou et al., 2009 [46] 1.2 NI, 1.3 PN
SC
Part1 : 2.1/2.2 Y, 2.3 PY, 2.4 PN
SC
Part2: 2.6N, 2.7 PN
SC
3.1 Y
LR
4.1 N, 4.2 N, 4.3 Y, 4.4 PN
LR
5.2/5.3 N 5.1 Y
LR
HR
Portier et al., 2006 [48] 1.2 NI, 1.3 PN
SC
Part1: 2.1/2.2 Y, 2.3 PY, 2.4 PN
SC
Part2: 2.6Y
LR
3.1 Y
LR
4.1 PY
HR
5.2/5.3 N 5.1 Y
LR
HR
Kemeny et al., 2002 [56] 1.2 NI, 1.3 PN
SC
Part1: 2.1/2.2 Y, 2.3 Y, 2.4 PN
SC
Part2: 2.6 N, 2.7 PY
HR
3.1 Y
LR
4.1 NI, 4.2 N, 4.3 Y, 4.4 PN
LR
5.2/5.3 N 5.1 Y
LR
HR
Tono et al., 2000 [57] 1.2 Y, 1.1 Y, 1.3 N
LR
Part1 : 2.1/2.2 Y, 2.3 N
LR
Part2: 2.6 PY
LR
3.1 Y
LR
4.1 N, 4.2 N, 4.3 Y, 4.4 PN
LR
5.2/5.3 N 5.1 Y
LR
LR
Kemeny et al., 1999 [58] 1.2 NI, 1.3 PN
SC
Part1: 2.1/2.2 Y, 2.3 Y, 2.4 NI, 2.5 NI HR
Part2: 2.6 Y, 2.7 PY
HR
3.1 Y
LR
4.1 N, 4.2 N, 4.3 Y, 4.4 PN
LR
5.2/5.3 N 5.1 Y
LR
HR
Rudroff et al., 1998 [59] ¹ 1.2 NI, 1.3 PN
SC
Part1: 2.1/2.2 Y, 2.3 PN
LR
Part2: 2.6 PY
LR
3.1 Y
LR
4.1 NI, 4.2 Y
HR
5.2/5.3 N 5.1 Y
LR
HR
Lorenz et al., 1998 [60] 1.2 Y, 1.1 NI, 1.3 PN
LR
Part1: 2.1/2.2 Y, 2.3 PY, 2.4 PN
SC
Part2 : 2.6Y
LR
3.1 Y
LR
4.1 N, 4.2 N, 4.3 Y, 4.4 PN
LR
5.2/5.3 N 5.1 Y
LR
SC

Abbreviations: LR: low risk; SC: some concern; HR: high risk. 1 The risk of bias assessment for this study focuses only on the comparison between groups A and B.