The time-weighted change from baseline in log10 tissue culture infective dose50 (TCID50/mL) was calculated on a by-subject basis through 48 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.

The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Overall, 83 subjects were excluded due to negative Baseline titers (log10 TCID50 0.5).

The time-weighted change from baseline in viral titer measured by RT-PCR was calculated on a by-subject basis through 216 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.

The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Overall, 41 subjects were excluded due to negative Baseline titers (viral particles/mL RT-PCR value 1.58 for Influenza A and 1.49 for Influenza B).

Time to clinical resolution was the number of hours from initiation of study treatment until 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) met resolution criteria that was maintained for at least 24 hours. The median time to clinical resolution and associated 95% confidence interval were estimated for each treatment group using the method of Kaplan-Meier. Subjects who did not achieve clinical resolution were censored at the time of their last assessment.

The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.

Clinical resolution was defined as normalization of at least 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) for at least 24 hours.

The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.

Time to alleviation of symptoms, defined as the time from initiation of study drug until the start of the 24 hour period where all seven symptoms of influenza are recorded as none or mild, was estimated using the method of Kaplan-Meier (adolescents and adults). The 95% confidence interval about the median was presented. Subjects who did not experience alleviation of symptoms were censored at the time of the last non-missing symptom assessment.

The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Symptom data for 18 subjects was missing.

Time to resolution of fever was the number of hours from initiation of study treatment until temperature was ≤37.2°C/≤99°F oral or ≤37.8°C/≤100°F rectal or tympanic for at least 24 hours with no antipyretic medication taken within 4 hours prior to the temperature measurement. Subjects who did not achieve resolution of fever were censored at the time of their last assessment. The 95% confidence interval about the median were presented.

The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.

Subject's ability to perform usual activities as determined from the visual analog scale (scale ranges from 0 to 10 where 0 indicates subject was unable to perform usual activities at all and 10 indicates subject is able to perform all usual activities fully) was summarized by study visit day and treatment group. The median time to resumption of usual daily activities and associated 95% CI was estimated using the method of Kaplan-Meier for adults and adolescents. Subjects who did not return to the pre-study level of performance of usual daily activities were censored at the time of their last non-missing visual analog scale value. A separate analysis was conducted for children.

The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.

Time to hospital discharge, defined as the number of days from initiation of study drug until the subject is discharged from the hospital, was estimated using the method of Kaplan-Meier. The 95% confidence interval about the median was presented. Subjects who were not discharged during the study period were censored at the last study visit. Subjects who died prior to discharge were censored at the longest observed time to discharge.

The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.

Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis and pneumonia as reported on the Influenza-related complications CRF.

The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.

The number of subjects experiencing ICU admission after initiation of treatment.

The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.

The duration of ICU admission after initiation of treatment was estimated by the method of Kaplan-Meier. Subjects who were not discharged from the ICU were censored at the time of their last assessment

The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.

The number of subjects who continued more than 5 days were as reported on the Continuation of Treatment CRF page.

The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.

Survival was calculated as the number of days from initiation of study drug until death or last contact. Overall survival was estimated by the method of Kaplan-Meier; 95% confidence intervals for 14- and 28-day survival were presented by treatment group. Subjects who had not died were censored at the date of last contact.

The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.