Handling of Missing Data Clause Samples

Handling of Missing Data. The AAS and BAS do not include any imputed values. Although missing data will occur, the influence of the missing data is expected to be minimal.

Handling of Missing Data. All data obtained in evaluable subjects/eyes will be used. No imputation for missing values will be carried out. Incidence and reasons for discontinuation by lens group will be tabulated at each visit and overall.

Handling of Missing Data. All attempts will be made to limit the amount of missing data. Unless otherwise specified, no attempt will be made to impute missing data. If a data point is missing, that data point will not contribute to that portion of the analysis. The number of evaluable observations will be reported in analysis so that extent of missing data can be assessed.

Handling of Missing Data. Plasma concentrations that are below the limit of quantification (BLQ) will be treated as zero for descriptive statistics. Mean BLQ concentrations will be presented as BLQ, and the SD and CV will be reported as not applicable. Missing concentrations will be excluded from the calculations. For the PK analysis, BLQ values will be treated as zero with the exception that a BLQ value between 2 quantifiable concentrations will be set as missing. Missing concentrations will be treated as missing from the PK parameter calculations. If consecutive BLQ concentrations are followed by quantifiable concentrations in the terminal phase, those concentrations after BLQ concentrations will be treated as missing.

Handling of Missing Data. Every attempt will be made to avoid missing data. All participants will be used in the analyses, as per the analysis populations, using all nonmissing data available. No imputation process will be used to estimate missing data. A sensitivity analysis will be used to investigate the impact of missing data if ≥5% of participants in any treatment group have missing data.

Handling of Missing Data. In general, observed data will be used in statistical analysis without imputation, unless missing data will jeopardize the integrity of the study or pose a problem in the validity of the analysis. A data-as-observed (DAO) approach will be used to evaluate the primary endpoint. Uncertain viral load measurements that are below the lower limit of quantification (LLOQ) will be set to 0.5 × LLOQ in the viral load summaries and indicated as BLQ in the listings. Impact of missing data will be assessed, and sensitivity analysis will be performed when deemed appropriate. Details will be described in the SAP.