<endpoint> <point <point <point (<statistic>) estimate> estimate> estimate> <variability <variability> <variability> <variability> statistic> Effect estimate per <Co->Primary Comparison groups <group descriptors> comparison endpoint {as per above terminology} {add as many rows as needed to describe the <test statistic> {e.g. <point estimate> relevant statistical difference between testing performed} groups} <variability statistic> <variability> {e.g. confidence interval, etc} P-value {indicate <P-value> statistical test used, e.g. ANOVA} <<Co->Primary > Comparison groups <group descriptors> <Secondary><ot her: specify> <test statistic> <point estimate> endpoint <variability statistic> <variability> {indicate endpoint P-value <P-value> using terminology as per section “Endpoint and definitions} <<Co->Primary > Comparison groups <group descriptors> <Secondary><ot her: specify> <test statistic> <point estimate> endpoint <variability statistic> <variability> P-value <P-value> <free text> Notes {consider amongst others the following information: reasons for drop-outs critical findings with regard to the analysis} Analysis description <Secondary analysis> <Co-primary Analysis> <Other, specify: > {also indicate if the conduct of the analysis was pre-specified} {repeat all the above sections for analysis that is each considered relevant} Clinical studies in special populations Special studies e.g. in children, in the elderly and in patients with renal or hepatic impairment. Describe these studies as suggested for the main studies including considerations on dose adjustments. Age 65-74 Age 75-84 Age 85+ (Older subjects (Older subjects (Older subjects number /total number /total number /total number) number) number) Controlled Trials
<endpoint> (<statistic>) <variability statistic> <point estimate> <variability> <point estimate> <variability> <point estimate> <variability> Effect estimate per comparison {add as many rows as needed to describe the relevant statistical testing performed} <Co->Primary endpoint Comparison groups <group descriptors> {as per above terminology} <test statistic> {e.g. difference between groups} <point estimate> <variability statistic> {e.g. confidence interval, etc} <variability> P-value {indicate statistical test used, e.g. ANOVA} <P-value> <<Co->Primary > <Secondary><ot her: specify> endpoint {indicate endpoint using terminology as per section “Endpoint and definitions} Comparison groups <group descriptors> <test statistic> <point estimate> <variability statistic> <variability> P-value <P-value> <<Co->Primary > <Secondary><ot her: specify> endpoint Comparison groups <group descriptors> <test statistic> <point estimate> <variability statistic> <variability> P-value <P-value> Notes <free text> {consider amongst others the following information: reasons for drop-outs critical findings with regard to the analysis} Analysis description <Secondary analysis> <Co-primary Analysis> <Other, specify: > {also indicate if the conduct of the analysis was pre-specified} {repeat all the above sections for analysis that is each considered relevant} Clinical studies in special populations Special studies e.g. in children, in the elderly and in patients with renal or hepatic impairment. Describe these studies as suggested for the main studies including considerations on dose adjustments. Age 65-74 (Older subjects number /total number) Age 75-84 (Older subjects number /total number) Age 85+ (Older subjects number /total number) Controlled Trials
WC500187042.docx