Table 1. Baseline Characteristics of the Participants.

	WR279,396 (N = 50)	Placebo-Vehicle (N = 42)	P Value
Center – no. (%)
Paris, France	5 (10)	5 (12)	1.0
Sidi Bouzid, Tunisia	45 (90)	37 (88)
Male sex – no. (%)	27 (54)	27 (64)	0.40
Age <18 years – no. (%)
Overall	47 (94)	33 (79)	0.034
Paris, France (N = 10)	2 (40)	0 (0)
Sidi Bouzid, Tunisia (N = 82)	45 (100)	33 (89)
Lesions – no. (%)
1	28 (56)	26 (62)	0.67†
2	9 (18)	7 (17)
3	9 (18)	4 (10)
4 or 5	4 (8)	5 (12)
Total lesion area – mm2
Median	128	154	0.52
Interquartile range	85 to 223	70 to 264
Index lesion area – mm2
Median	92	115	0.34
Interquartile range	55 to 141	50 to 172
Index lesion on upper body – no. (%)	20 (40)	17 (40)	1.0
Index lesion on extremity – no. (%)	48 (96)	42 (100)	0.50
Days before treatment since lesion first noticed
Median	62	62	0.96
Interquartile range	38 to 79	39 to 79
Leishmania species – no. (%)
L. major	32* (64)	24* (57)	0.53‡
L. infantum	1 (2)	0 (0)
L. tropica	1 (2)	0 (0)
Unidentified	16 (32)	18 (43)

Comparisons of categorical variables use the Fisher's exact test for the entire study cohort, while comparisons of continuous variables use the Wilcoxon rank-sum test.

†: Compares the proportion of participants in each group with a sole lesion at baseline.

*: Species identification was by isoenzyme electrophoresis (18 isolates), PCR (50 isolates) or both techniques (8 isolates). All isolates identified by both techniques were from Tunisia and all belonged to the L. major MON-25 zymodem (the only L. major zymodem reported from the Maghreb). In France, identification was by isoenzyme electrophoresis in 8 cases as follows: L. major MON-25 (5 isolates), L. infantum MON-24, L. major MON-26, L. major MON-74 (1 isolate each).

‡: Compares the proportion of participants in each group with L. major identified.