{"denoms":[{"counts":[{"groupId":"BG000","value":"155"}],"units":"Participants"}],"groups":[{"description":"Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals. Doses were up-titrated at Days 28 and 56 if the measured T-concentration in a NaF/EDTA plasma sample was below 400 ng/dL; down-titrated if the T-concentration was above 900 ng/dL, and no change if between those thresholds.\n\nSOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.","id":"BG000","title":"SOV2012-F1-treated"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"9.41","value":"50.5"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"155"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"99"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"29"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"119"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"59"}]}],"title":"<= 93 kg"},{"categories":[{"measurements":[{"groupId":"BG000","value":"96"}]}],"title":"> 93 kg"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Weight at Baseline","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"7.343","value":"33.95"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Body Mass Index (BMI)","unitOfMeasure":"kg/m^2"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"13"}]}],"title":"Low-fat breakfast"},{"categories":[{"measurements":[{"groupId":"BG000","value":"53"}]}],"title":"Normal-fat breakfast"},{"categories":[{"measurements":[{"groupId":"BG000","value":"80"}]}],"title":"High-fat breakfast"},{"categories":[{"measurements":[{"groupId":"BG000","value":"9"}]}],"title":"Missing"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Assigned breakfast diet","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"34"}]}],"title":"With Diabetes Mellitus"},{"categories":[{"measurements":[{"groupId":"BG000","value":"121"}]}],"title":"Without Diabetes Mellitus"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Diabetic Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"96"}]}],"title":"Hypertensive"},{"categories":[{"measurements":[{"groupId":"BG000","value":"56"}]}],"title":"Not hypertensive"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}],"title":"Missing"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Hypertensive Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"56"}]}],"title":"With Antihypertensive Therapy at Visit 7E (Day 1 E)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"99"}]}],"title":"Without Antihypertensive Therapy at Visit 7E (Day 1 E)"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Hypertensive Treatment Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8"}]}],"title":"Primary"},{"categories":[{"measurements":[{"groupId":"BG000","value":"147"}]}],"title":"Secondary"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Hypogonadal Status","unitOfMeasure":"Participants"}]}