After sentence beginning "A total of 44 and 27 sites", insert new sentence "Of these, 37 and 25 sites (studies 414 and 514, respectively) enrolled patients in strata 1 and 2." The percentages cited in the following sentence refer to patients in strata 1 and 2 only.

"Not available" count for Placebo Gel should be 12 (instead of 3)

"Prior to the protocol amendment, the median cumulative dose administered to the MTT…" should be "the median cumulative dose administered to the patient"

"No. (%) of visits where ³ 80% of assigned dose delivered" should read "No. (%) of patients having cumulative percentage of assigned dose administered to MTT ³ 80%" [i.e., ratio of cumulative dose administered to cumulative dose assigned at least 0.8]

"No. (%) of visits where ³ 80% of assigned dose delivered" should read "No. (%) of patients having cumulative percentage of assigned dose administered to MTT ³ 80%" [i.e., ratio of cumulative dose administered to cumulative dose assigned at least 0.8] and row counts and percentages in the last three cells should be changed to:

All comparisons presented in Table 32 are stratified by study. The "Strata 1 & 2" comparison is stratified by both study and MTT stratum. There are no unstratified comparisons. Hence, the footnote symbols for the Stratum 1 and Stratum 2 p-values should be changed from "b" to "a" and footnote b should be deleted.

Minimum observed durations were 30+, 36+, and 30+ for Stratum 1, Stratum 2, and Strata 1 & 2, respectively [see Tables A2-1 and A2-2 in Appendix 2 for complete list of durations].

"A total of 160 of the 178 patients … went on to receive open label treatment with CDDP/epi gel after initial treatment in the blinded treatment phase."

"A total of 160 of the 178 patients had MTTs treated with CDDP/epi gel during either the blinded treatment phase or the open label phase."

"Data on the association of Patient Benefit and objective MTT response are provided in Tables 38 – 40 for studies 414, 514, and combined."

"Data on the association of Patient Benefit and objective MTT response are provided in Table 48 for the studies combined."

"Chi-squared test" should read "Exact Cochran-Mantel-Haenszel test"

"Chi-squared p-value" should read "Exact Cochran-Mantel-Haenszel p-value"

57/59 should read 5/59

"Exact Cochran-Mantel-Haenszel test; chi-squared p-value <0.005 for association of this outcome with MTT response."

"Exact Cochran-Mantel-Haenszel test; exact Cochran-Mantel-Haenszel p-value 0.005 for association of this outcome with MTT response."

"87 patients" should read "88 patients"; as discussed below, the patient who did not receive study medication, although the syringe was inserted, was included in safety analyses

Hemmorrhage [sic] for Placebo Gel, Severe should be 1 (1%) (instead of 0 (0%))

"Fifty percent of the group randomized to CDDP/epi gel experienced at least one clinically significant increase in blood pressure during dosing."

"Sixty-six percent of the group randomized to CDDP/epi gel experienced at least one clinically significant increase in blood pressure during dosing." [Overall incidence during the treatment phase was 99/150 (NDA T-14.3-14).]

c: includes decreased hearing and hearing loss.

"p=0.047" should be "p=0.046" [see Table 42]

Treatment Group column should read "Placebo Gel" for patients 2064, 5277, 2159 and 5302

Treatment Group column should read "Placebo Gel" for patient 5495

column heading "Goal type" should read "Primary goal type"

"While the median number of blinded treatment visits was for" should read "While the median number of blinded treatment visits was four"

"Other" should be 7 (23%) (instead of 7 (2%))

Stratum 3, last column, Exact p should be 0.27 (instead of 0.15)

Stratum 1, Placebo Gel, 95% CI should be 0.087-18% (instead of 0.87 – 18%)