Table 2.

Overview of outcomes reported in the studies

Study	Incident oral infection	Persisting oral infection	Incident anogenital infection		Persisting anogenital infection		Condyloma acuminatum		AIN grade 2	AIN grade 3 or carcinoma	PIN grade 2	PIN grade 3 or carcinoma	Severe adverse events
			Anogenital	Anal	Anogenital	Anal	Genital	Anal
Randomized trials
Giuliano et al. 2011 [32]			x		x		x				xa	xa	x
Palefsky et al. 2011 [33]				x		x		x	x	x			xb
Coskuner et al. 2014 [31]							x
NCT01461096 [26]		x
Non-randomized studies
Swedish et al. 2012 [25]									xc	xc
Swedish and Goldstone 2014 [34]								x
Kahn et al. 2015 [24]	x

^aPIN 2 and PIN 3 analysed together

^bSubgroup of Giuliano et al. [32]; therefore, all severe adverse events already reported there

^cdefined as “high-grade anal intraepithelial neoplasia”, comprising AIN 2 and AIN 3 (Goldstone, personal communication). Applying a conservative approach, results are reported here as AIN 2