Table 3B: Level of Evidence of Studies Included in the Review.

Study Design	Level of Evidence	Number of Eligible Studies
Large RCTs	1	1
Large RCT unpublished but reported to an international scientific meeting	1(g)	1
Small RCT	2	3
Small RCT unpublished but reported to an international scientific meeting	2(g)
Non-RCT with contemporaneous controls (prospective)	3a	3
Non-RCT with historical controls	3b
Non-RCT presented at international conference	3(g)
Surveillance (database or register)	4a
Case series (multisite)	4b
Case series (single site)	4c
Retrospective review, modelling	4d
Case series presented at international conference	4(g)
Total number of primary studies		8

g= literature

^*RCT represents randomized controlled trial; HTA, health technology assessment