Monzani 2004

Methods	1. Generation of allocation sequence: List of randomization obtained using the software Procplan SAS 2. Allocation concealment: In a blinded manner, 3. Blinding: Double‐blinding 4. Sample size calculation: No clear description 5. Loss to follow‐up: None 6. Intention‐to‐treat analysis: Not cleary described 7. Similarity between groups: Yes, in age and others, except in serum basal TSH, FT4, CT, LDLc and IMT. 8. Number of randomized patients: 45 ( 23 thyroxine and 22 placebo)
Participants	1. Inclusion criteria: Normal serum free thyroxine (FT4) 5,6 ‐ 13pg/mL and TSH levels between 3,65 ‐ 15mIU/lL (normal = 0,3 ‐ 3,6 mIU/mL); with history of previous radioiodine therapy for toxic adenoma or multinodular toxic goiter, thyroid disease or Hashimoto's thyroiditis. 2. Exclusion criteria: Individuals over age > 55yr, obese (BMI > 30 kg/m2) individuals; individuals with hypertention, diabetes mellitus, renal and hepatic failure, and postmenopausal women. 3. Characteristics (Age (mean (SD)), gender, ethnicity, other): Age 37 +/‐11 yr; female = 37 and male = 8; BMI = 24,7 +/‐ 11,5 kg/m2.
Interventions	1. Intervention in experimental group (including number of patients, dosage, mode of administration, duration of treatment): N=23, thyroxine median = 70mcg/d. Six months after the normalization of serum TSH levels (median 10.5 months, range 9 ‐ 15 from the beginning of the study). 2. Intervention in control group 1 (including number of patients, dosage, mode of administration, duration of treatment): N=22, placebo not described. Six months after the normalization of serum TSH levels (median 10.5 months, range 9 ‐ 12 from the beginning of the study).
Outcomes	1. Total cholesterol (TC), enzymatic methods (Roche Diagnostics, Mannheim, Germany). 2. Triglycerides (TG), enzymatic methods (Roche Diagnostics, Mannheim, Germany). 3. High‐density lipoprotein cholesterol (HDLc), Mg2+‐dextran (Roche Diagnostics). 4. LDL cholesterol (LDLc), Mg2+‐dextran (Roche Diagnostics). 5. Apolipoprotein A1 (ApoA1), immunochemically (Nephelometer, Behring Diagnostics, Marburg, Germany). 6. Apolipoprotein B (ApoB), immunochemically (Nephelometer, Behring Diagnostics, Marburg, Germany). 7. Lp(a), nephelometry (N latex Lp(a) reagent, Behring Diagnostics). 8. Total homocysteine tHcy was measured by HPLC 9. Ac. folico specific RIA (ICN Pharmaceuticals, Costa Mesa, CA). 10. Vit. B12, specific RIA (ICN Pharmaceuticals, Costa Mesa, CA). 11. Carotide artery intima‐media thickness (IMT) ‐ maximal IMT (mm), median IMT (mm) with high‐resolution ultrasonography (SONOS 2500, Hewlett‐Packard, Andover, MA) and a 7.5‐MHz linear transducer (Hewlett‐Packard). 12. FT4 specific RIA (Techno‐Genetics Recordati, Milan, Italy). 13. TSH ultrasensitive immunoradiometric assay (IRMA) method (Cis Diagnostici, Tronzano Vercellese, Italy). 14. BMI 15. Blood pressure Duration of follow‐up: Six months after the normalization of serum TSH levels (median 10.5 months, range 9 ‐ 15 from the beginning of the study).
Notes	1. Setting: Outpatient Clinic of the Department of Internal Medicine of the University of Pisa, Italy. 2. Funding source: None mentioned.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate