Table 2.

Methodic assessment of the included studies.

Author, Year	Study Design	Risk of Bias Assessment
		The Newcastle–Ottawa Scale				The Cochrane Tool
		Selection (0–3)	Comparability (0–2)	Outcome (0–3)	Total (Risk of Bias)	Risk of Bias
Benova et al., 2018 [22]	prospective	4	2	2	8 (Low)
Chu-Shore et al., 2009 [2]	retrospective, comparative	4	2	3	9 (Low)
Chu-Shore et al., 2010 [23]	retrospective comparative	4	2	3	9 (Low)
Hulshof et al., 2021 [14]	retrospective cohort	4	2	3	9 (Low)
Jeong et al., 2017 [12]	retrospective, multicenter, from TSC Natural History Database Project	4	2	3	9 (Low)
Jozwiak et al., 2011 [30]	prospective, nonrandomized clinical trial	4	2	3	9 (Low)
Jóźwiak et al., 2019 [29]	prospective, nonrandomized clinical trial	3	2	3	8 (Low)
Kotulska et al., 2014 [10]	retrospective	4	2	3	9 (Low)
Kotulska et al., 2021 [24]	multicenter, prospective, randomized clinical trial and partially open-label	-	-	-	-	Low
Mert et al., 2019 [26]	retrospective	4	2	3	9 (Low)
Monteiro et al., 2014 [27]	retrospective	3	0	2	5 (Moderate)
Ogórek et al., 2020 [28]	randomised control and non-randomised open-label	-	-	-	-	Low
Peron et al., 2018 [19]	retrospective	4	2	3	9 (Low)
Savini et al., 2020 [25]	retrospective	3	1	3	7 (Low)
de Ridder et al., 2021 [33]	multicenter, prospective, randomized	-	-	-	-	Low
Vignoli et al., 2013 [21]	retrospective	4	2	3	9 (Low)
Vignoli et al., 2021 [20]	retrospective	4	2	3	9 (Low)
Winterkorn et al., 2007 [31]	retrospective	4	2	3	9 (Low)
Zhang et al., 2018 [32]	retrospective	4	2	3	9 (Low)