STATISTICAL ANALYSIS/ RESULTS Power Calculation: Based on the cure rates of the phase II clinical trial on the efficacy

of the apple cider vinegar vs salicylic lactic acid in the treatment of common warts, which yielded 36% and 74%, and setting alpha at 0.05, sample size of at least 51 lesions per group has 98% power.

A. Patients/ Subjects & Common Warts Sample Descriptives

S ex Apple Cider Salicylic Lactic Acid Total

Male 5 11 16 23% 48% 36%

F ale em 17 77% 12 52% 29 64%

Total 22 23 45

49% 51% 100%

Out of the total 45 subjects, 36% are male and 64% are female. On either group, most of the patients are female (A = 77%, B = 52%). The mean age of the patients who received apple-cider vinegar treatment is 22.68 + 15.8 years, while those of the patients who received salicylic-lactic acid treatment is 24.61 + 15.5 years. 104 common warts in 45 patients were included in the study. 53 common warts in 22 patients were subjected to Apple Cider Vinegar treatment while 51 common warts in 23 patients were subjected to Salicylic-Lactic Acid treatment. In the apple cider group, the mean number of warts per patient was 2.41 + 1.9. In the salicyliclactic acid group, the mean number of warts per patient was 2.22 + 1.9. Three patients (two from apple-cider group, one from salicylic-lactic acid group) with a total of four common warts (3 from apple cider group, 1 from salicylic-lactic acid group) were not able to comply with the 4-week maximum clinical trial.
Duration of Lesions (% per group) - 3 Mos 1 Mo Apple Cider Vinegar 6 (27%) Salicylic-Lactic Acid 12 (52%) TOTAL 18 (40%) 4 - 6 M os 5 (23%) 4 (17%) 9 (20%) 7 - 11 Mos 4 (18%) 0 (0%) 4 (9%) 1 Yr 4 (18%) 4 (17%) 8 (18%) 2 Yrs 3 (14%) 1 (4%) 4 (9%) > 2 Yrs 0 (0%) 2 (9%) 2 (4%) TOTAL 22 (100%) 23 (100%) 45 (100%)

Most of the lesions in both groups had a duration of 1 month to 3 months (27% in apple cider; 52% in salicylic-lactic acid). B. Cure Rate

Apple Cider Vinegar Salicylic-Lactic Acid TOTAL

Not C ured 5 9% 11 22% 1 6 1% 5

C ured 45 85% 39 76% 8 4 81 %

Miss / Inc ing 3 6% 1 2% 4 4 %

TOTAL 53 51% 51 49% 1 04 1 % 00

The cure rate for the apple cider group and salicylic-lactic acid group were 85% (45/53) and 76% (39/51), respectively. Overall, cure rate for the clinical trial was 81%. Excluding the missing samples, the difference in cure rates were statistically tested using the Chi-Square Test. There is no sufficient evidence to prove that there is a significant difference between the cure rates of apple cider treatment and salicylic-lactic acid treatment (p=0.102). Intention to Treat Analysis:

Cured Not Cured Missing / Lost to ff up C R ure ates(% ): Complete Case Analysis Assuming good outcome Assuming poor outcome

Apple C ider (n= 53) 45 5 3

S alicylic-L actic Acid (n=51) 39 11 1

C quare Test hi-S P-value (vs0.05) ----

90 (45/50) 90.6 (48/53) 84.9 (45/53)

78 (39/50) 78.4 (40/51) 76.5 (39/51)

0.102 (not sig. diff) 0.086 (not sig. diff) 0.275 (not sig. diff)

Complete case analysis ignores all those who were not able to complete the clinical trial. Assuming good outcome assumes those that were lost to follow up were cured, while assuming poor outcome assumes those that were lost to follow up were not cured. Chi-square test results in all three scenarios show that there is no sufficient evidence to prove that the cure rates between the apple cider group and the salicylic-lactic acid group are significantly different.

C. Decrease in Size of Warts

At Day 0 of the clinical trial, the common warts had a mean size of 0.499cm in the apple cider group and 0.481cm in the salicylic-lactic acid group. For both T-test for Independent Samples (p=0.296) and Mann-Whitney Test (p=0.425), there is no sufficient evidence to prove that the mean sizes at Day 0 of the two groups are significantly different. Therefore, a comparison between the mean size decrease of the common warts at the end of the clinical trial can be performed.

The size of common warts in the apple cider group decreased by an average of 0.441cm, while the size of the common warts in the salicylic-lactic acid group decreased by an average of 0.375cm. With p=0.087 resulting from the T-Test for Independent Samples and with p=0.086 resulting from the Mann-Whitney Test, there is no sufficient evidence to prove that the mean size decrease between the two groups are significantly different.

D. Number of Days to Cure

Mean time to cure among apple cider group and among salicylic-lactic acid group were 20 and 18 days, respectively. There is a significant difference between the two groups mean time to cure (p=0.026), with the salicylic-lactic acid group showing a better clinical response across time.

E. Incidences of Adverse Effects

GROUP * Hypopigmentation Crosstabulation Count Hypopigmentation NO GROUP Apple Cider Vinegar Salicylic Acid + Lactic Acid Total 49 46 95 YES 1 4 5 Total 50 50 100

Except for Maceration (p=0.006), there is no significant difference in the incidences of adverse reaction between the two groups.
Seco ndary B acterial In fectio n O th ers 0 0 0 0

A p p le C id e r V in e ga r Sa licylic-Lactic A cid

Erythem a 2 2

M aceratio n Hypo pigm en tatio n H yperpigm en tatio n Blistering Pain/ Tendern essScarrin g 0 1 0 1 0 1 8 4 0 0 0 0

In the apple cider group, 2 patients had erythema, 1 had hypopigmentation, 1 had blisters and another 1 experienced scarring. In the salicylic-lactic acid group, 2 had erythema, 8 had maceration and 4 had hypopigmentation.

F. Disease Control

Among the apple cider group, 45 (84.9%) out of 53 common warts were cleared or resolved, 1 (1.9%) common wart showed improved or evident clearance and 4 (7.5%) common warts were partially cleared. Among the salicylic-lactic acid group, 39 (76.5%) out of 51 common warts were cleared or resolved, 1 (2.0%) common wart showed improved or evident clearance and 10 (19.6%) common warts were partially cleared.

66.7% (56/84) of cleared or resolved common warts were already soft on palpation prior to curettage while 29.8% (25/84) were doughy. Common warts which showed improved or evident clearance were all already soft. Of those common warts which were partially cleared, 71.4% (10/14) were also already soft.