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. 2018 Mar 19;12(7):E349–E356. doi: 10.5489/cuaj.4898

Supplementary Table 1.

Exclusion criteria

Subjects were entered into the study only if they met none of the following criteria
  1. Personal/family history of allergy or hypersensitivity to testosterone or related drugs

  2. Past history of anaphylaxis or angioedema

  3. Any major illness in the past 3 months or any clinically significant ongoing chronic medical illness (e.g., congestive heart failure, hepatitis, pancreatitis, etc.)

  4. Presence of any clinically significant abnormal values during screening (e.g., significant abnormality of liver function test [LFT], renal (kidney) function test [RFT], etc.)

  5. Hemoglobin <13 g/dL or hematocrit >52% during screening

  6. Any cardiac, renal, or liver impairment; any other organ or system impairment

  7. Asthmatic subjects with a forced expiratory volume in 1 second (FEV1) predicted <80%

  8. History of seizure or clinically significant psychiatric disorders

  9. Presence of disease markers for human immunodeficiency virus (HIV) 1 and/or 2, Hepatitis B and/or C (HBsAg and/or HCV) virus

  10. History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty (“nose job”), or sinus surgery

  11. Subjects with prior nasal fractures

  12. Subjects with mucosal inflammatory disorders, specifically pemphigus, or Sjogren’s syndrome, rhinitis sicca

  13. Subjects with sinus disease, specifically acute sinusitis, chronic sinusitis, or allergic fungal sinusitis

  14. History of nasal disorders (e.g., polyposis, recurrent epistaxis [>1 nose bleed per month]), abuse of nasal decongestants, or sleep apnea

  15. Subjects using any form of intranasal medication delivery, specifically nasal corticosteroids and oxymetazoline at the time of screening/enrolment

  16. History of asthma and/or ongoing asthma treatment

  17. Regular drinkers of more than 3 units of alcohol daily (1 unit = 300 mL beer, 1 glass wine = 200 mL, 1 measure spirit = 1 cL of pure alcohol), or consumption of alcohol within 48 hours prior to dosing and during the study

  18. Subjects demonstrating a positive test for alcohol consumption (using breath alcohol analyzer) at the time of check-in during the admission periods

  19. History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit, before the start of this study

  20. Subjects demonstrating a positive test for drugs of abuse in urine (opiates, benzodiazepines, amphetamines, tetrahydrocannabinol [THC], and cocaine) at the time of check-in during admission periods

  21. Inaccessibility of veins in left and right arms

  22. Receipt of any prescription drug therapy within 4 weeks of the first admission period

  23. Prescription medication and difficulty in abstaining from over-the-counter (OTC) medication (except occasional paracetamol/aspirin) for the duration of the study

  24. Subjects demonstrating serum PSA ≥4 ng/mL

  25. Participation in any other research study involving an investigational new product or device (IND) or studies that required blood sampling, during the conduct of this study or 30 days prior to screening of this study (Visit 1)

  26. Blood donation (usually 550 mL) at any time during this study, or within the 12-week period before study start