Table 1.

Measurements and methods for a randomized clinical trial of Tesomet for hypopituitary patients with hypothalamic obesity.

Measurement/assessment (unit)	Method
Adverse events
Mild/moderate/severe	MedDRA, version 22.0
Anthropometry^
Height (cm)	To the closest 0.1 cm using a wall-mounted stadiometer*
Weight (kg)	To the closest 0.1 kg on a pre-calibrated scale**
Waist (cm)	To the nearest 1.0 cm midway between lower costal edge and upper iliac crest.
Body composition^^	A trained operator performed all scans, Cvmax <1% for all DXA outcomes.
Fat mass (kg)
Lean mass (kg)
Bone mineral content (g)
Bone mineral density (g/cm2)
Biochemical assessment^^^
Total cholesterol (mmol/L)	Cobas CHOL 2 agent, CVmax 5% ***
HDL-cholesterol (mmol/L)	Cobas HDLC4 agent, CVmax 4% ***
LDL-cholesterol (mmol/L)	Cobas LDLC3 agent, CVmax 4% ***
Triglyceride (mmol/L)	Cobas TRIGL agent, CVmax 4% ***
Plasma glucose (mmol/L)	Cobas GLUC3 agent, CVmax 4% ***
HbA1c (mmol/mol)	Ion-exchange HPLC, CVmax 4%****
Questionnaires
Short form 36 v.2#	Physical component score and a mental component score using a standardized algorithm (37). Higher scores indicate higher self-perceived QoL.
PHQ-9##	Total depression score. The questionnaire scores nine depression DSM-IV criteria from 0 (not at all) to 3 (nearly every day).
Appetite (mm)	Visual analogue scale (100 mm). Appetite scores were summarized into a composite satiety score (CSS). Higher CSS represents a more full, satiated state with less hunger and lower prospective food consumption.
Food cravings (mm)	Visual analogue scale (100 mm). High values represent a low self-perceived desire for the food element in question.

^Anthropometry measurements were performed by a single trained staff member; ^^Full-body DXA scanner (ME+200588, GE Healthcare A/S), analysed using proprietary GE CoreScan software (GE Healthcare); ^^^Fasting venous blood samples were drawn for laboratory analyses at each visit; #Short Form 36 Health Survey Questionnaire version 2 (SF-36v2, Health Survey Standard, Denmark, Danish) (35, 36). ##Patient Health Questionnaire 9 (Danish version) (51, 52); *Without shoes in upright standing position with the back to the wall down (Seca stadiometer, Kirudan, Broendby, Denmark); **Weight was measured without shoes, in light clothing; ***Cobas 8000 c702 module photometric apparatus (Roche Diagnostics GmbH); ****Tosoh G8 analyzer (Sysmex Europe GmbH, Hamburg, Germany).