{"analyses":[{"ciLowerLimit":"-13.05","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.04","groupIds":["OG000","OG001"],"nonInferiorityComment":"The primary endpoint was to determine whether or not SJ-0021 is inferior to u-hFSH in inducing ovulation. The criterion for non-inferiority was that the lower limit of the two-sided 95% CI (= one-sided 97.5% CI) had to be greater than -15% for SJ-0021 to be considered not inferior to u-hFSH.\")","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"Delta","paramValue":"-3.51","statisticalMethod":"Chi-squared","testedNonInferiority":true}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"79.1"},{"groupId":"OG001","value":"82.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"132"}],"units":"Participants"}],"description":"Participants were considered to have ovulated if serum progesterone (P4) level was greater than or equal to 5 nanogram (ng)/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.","groups":[{"description":"SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.","id":"OG000","title":"SJ-0021"},{"description":"Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.","id":"OG001","title":"u-hFSH"}],"paramType":"NUMBER","populationDescription":"Full analysis set (FAS) included all participants who received at least 1 dose of IMP and had no major violation of Good Clinical Practice (GCP) such as non-compliance with the agreement, serious protocol violations, etc.","reportingStatus":"POSTED","timeFrame":"On Day 6±1 or 9±1 days during post-treatment assessment period (Day 35-42 of post-treatment period for clinical pregnancy)]","title":"Percentage of Participants With Ovulation","type":"PRIMARY","unitOfMeasure":"percentage of participants"}