Duration of main phase: <time> Duration of Run-in phase: <time> <not applicable> Duration of Extension phase: <time> <not applicable> Hypothesis <Superiority> < Equivalence> <Non-inferiority> <Exploratory: specify> Treatments groups <group descriptor> <treatment>. <duration>, <number {add as many rows {provide abbreviation for randomized> as needed to use later in the table of the describe the results section} treatment groups} <group descriptor> <treatment>. <duration>, <number randomized> <group descriptor> <treatment>. <duration>, <number randomized> Endpoints and <Co- <label> <free text> {provide brief description} definitions >Primary {generate {add as many rows endpoint abbreviation as needed to for use later describe the in the table endpoints; for the of the secondary endpoints results select the ones section} considered most <Secondary> <label> <free text> {provide brief description} relevant and <other: reported in the specify> results section} endpoint <Secondary> <label> <free text> {provide brief description} <other: specify> endpoint Database lock <date> Results and Analysis {present the result separate for each analysis that is considered relevant for the conclusion on the trial; in any case the pre-specified primary analysis should be presented} Analysis description Primary Analysis Analysis population <Intent to treat> <Per protocol> <other: specify> and time point {consider adding a brief description of the definition of the population} <time point> description Descriptive statistics Treatment group <group <group <group and estimate descriptor> descriptor> descriptor> variability {as per above {as per above {as per above terminology} terminology} terminology} Number of <n> <n> <n> subject <endpoint> <point <point <point {label as above} estimate> estimate> estimate> (<statistic>) {e.g. mean, median, etc} <variability <variability> <variability> <variability> statistic> {e.g. standard deviation, confidence interval, etc} <endpoint> <point <point <point (<statistic>) estimate> estimate> estimate> <variability <variability> <variability> <variability> statistic>
Duration of main phase: Duration of Run-in phase: Duration of Extension phase: <time> <time> <not applicable> <time> <not applicable> Hypothesis <Superiority> < Equivalence> <Non-inferiority> <Exploratory: specify> Treatments groups {add as many rows as needed to describe the treatment groups} <group descriptor> {provide abbreviation for use later in the table of the results section} <treatment>. <duration>, <number randomized> <group descriptor> <treatment>. <duration>, <number randomized> <group descriptor> <treatment>. <duration>, <number randomized> Endpoints and definitions {add as many rows as needed to describe the endpoints; for the secondary endpoints select the ones considered most relevant and reported in the results section} <Co- >Primary endpoint <label> {generate abbreviation for use later in the table of the results section} <free text> {provide brief description} <Secondary> <other: specify> endpoint <label> <free text> {provide brief description} <Secondary> <other: specify> endpoint <label> <free text> {provide brief description} Database lock <date> Results and Analysis {present the result separate for each analysis that is considered relevant for the conclusion on the trial; in any case the pre-specified primary analysis should be presented} Analysis description Primary Analysis Analysis population and time point description <Intent to treat> <Per protocol> <other: specify> {consider adding a brief description of the definition of the population} <time point> Descriptive statistics and estimate variability Treatment group <group descriptor> {as per above terminology} <group descriptor> {as per above terminology} <group descriptor> {as per above terminology} Number of subject <n> <n> <n> <endpoint> {label as above} (<statistic>) {e.g. mean, median, etc} <point estimate> <point estimate> <point estimate> <variability statistic> {e.g. standard deviation, confidence interval, etc} <variability> <variability> <variability> <endpoint> (<statistic>) <point estimate> <point estimate> <point estimate> <variability statistic> <variability> <variability> <variability>
WC500187042.docx