Study identifier <code> Design <free text> 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 randomized> <group descriptor> <treatment>. <duration>, <number randomized> <group descriptor> <treatment>. <duration>, <number randomized> Endpoints and <label> <free text> definitions endpoint <Secondary> <label> <free text> <other: specify> endpoint <Secondary> <label> <free text> <other: specify> endpoint Database lock <date> Results and Analysis Analysis description Primary Analysis Analysis population <Intent to treat> <Per protocol> <other: specify> and time point <time point> description Descriptive statistics Treatment group <group <group <group and estimate descriptor> descriptor> descriptor> variability Number of <n> <n> <n> subject <endpoint> <point <point <point (<statistic>) estimate> estimate> estimate> <variability <variability> <variability> <variability> statistic> <endpoint> <point <point <point (<statistic>) estimate> estimate> estimate> <variability <variability> <variability> <variability> statistic> <endpoint> <point <point <point (<statistic>) estimate> estimate> estimate> <variability <variability> <variability> <variability> statistic> Effect estimate per <Co->Primary Comparison groups <group descriptors> comparison endpoint <test statistic> <point estimate> <variability statistic> <variability>
Study identifier <code> Design <free text> 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 randomized> <group descriptor> <treatment>. <duration>, <number randomized> <group descriptor> <treatment>. <duration>, <number randomized> Endpoints and definitions endpoint <label> <free text> <Secondary> <other: specify> endpoint <label> <free text> <Secondary> <other: specify> endpoint <label> <free text> Database lock <date> Results and Analysis Analysis description Primary Analysis Analysis population and time point description <Intent to treat> <Per protocol> <other: specify> <time point> Descriptive statistics and estimate variability Treatment group <group descriptor> <group descriptor> <group descriptor> Number of subject <n> <n> <n> <endpoint> (<statistic>) <point estimate> <point estimate> <point estimate> <variability statistic> <variability> <variability> <variability> <endpoint> (<statistic>) <point estimate> <point estimate> <point estimate> <variability statistic> <variability> <variability> <variability> <endpoint> (<statistic>) <point estimate> <point estimate> <point estimate> <variability statistic> <variability> <variability> <variability> Effect estimate per comparison <Co->Primary endpoint Comparison groups <group descriptors> <test statistic> <point estimate> <variability statistic> <variability>
WC500187047.docx