Table 1.

Publications of mycobacterial cell wall nuclear acid complex treatment efficacy.

Authors	Design	Patients	Treatment	Median follow-up	Overall 1-year disease-free survival	Major adverse effects (%)
Morales et al. [2009]	Single-arm prospective multicenter trial	n = 55, BCG naïve and BCG failures, CIS ± papillary	4 mg versus 8 mg dose. Six-week induction plus 1-week maintenance monthly × 12 months	Unknown, limited	4 mg – 27% 8 mg – 46%	4 mg – 32% 8 mg – 33%
Morales et al. [2015]	Phase III single-arm prospective multicenter trial	n = 129, BCG failures only, CIS ± papillary and papillary only	8 mg dose. Six-week induction plus 3-week maintenance at 3, 6, 12, 18, 24 months	34 months	25%	14%

BCG, bacillus Calmette–Guérin; CIS, carcinoma in situ.