Outcome measures
BBS
SECONDARY
Outcome measurements were performed at the baseline, placebo (either week 12 or 26) and testosterone (either week 12 or 26) arms. The primary outcome measure was improvement in quadriceps isokinetic muscle strength assessed using a HUMACNORM isokinetic dynamometer (Stoughton, Massachusetts, USA) on the right leg at 30 and 60 degrees from full extension (0 degrees). Many studies have demonstrated inter-test reliability using the HUMACNORM isokinetic dynamometer [These secondary outcomes were used as they are commonly employed in the clinical and research setting. The Berg Balance Scale (BBS) is used to assess balance through a series of static and dynamic activities. The BBS has high inter-rater reliability (intraclass correlation coefficient = 0.99) and test-retest reliability (intraclass correlation coefficient = 0.98) in older populations [Patient reported outcomes regarding physical function and quality of life were assessed using the IBM-Functional Rating Scale (IBM-FRS) and the RAND Short Form 36 (RAND-SF-36) respectively [No changes were made to primary or secondary outcomes once the trial had commenced. The OLE study utilised the main study endpoints. Some timepoint deviations occurred during the OLE due to due to Coronavirus-related disruption.