6.6. Pregnancy in Partners of Male Patients Sexually active male patients are required to use a medically acceptable form of birth control while receiving study treatment and for a period of 4 months following the last study treatment injection. It is unknown whether galinpepimut-S affects the sperm or could be transmitted to the patient’s partner during sexual activity. The effect of galinpepimut-S on the fetus is unknown. If a male patient’s partner becomes pregnant, the pregnant partner will be requested to sign a pregnant partner consent form. The pregnancy will be followed-up to determine the outcome (including complications, spontaneous miscarriage, elective termination, normal birth, or congenital abnormality) and status of mother and child . The occurrence of pregnancy and the outcome of any pregnancy in a partner of a patient treated with galinpepimut-S must be reported to SELLAS (via its CRO, Cancer Insight, LLC) and to the pertinent IRB. Any partner pregnancy that is brought to the site investigator’s attention after the patient has completed the study with a timeframe of pregnancy that coincides with the study treatment period or within 4 months following the last study treatment injection or that has an outcome (such as a miscarriage) considered by the site investigator as possibly related to the study treatment must be promptly reported to SELLAS . 6.7. Laboratory Analyses Laboratory analyses are provided in Table 9 and detailed below. SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/ MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 200 Blood samples will be drawn for coagulation (INR, PT, PTT ), hematology (CBC with differential and platelet count), serum chemistry (sodium, potassium, chloride, carbon dioxide, blood urea nitrogen, creatinine, calcium, total protein, albumin, glucose, total bilirubin, alkaline phosphatase, AST , ALT , and lactate dehydrogenase), and thyroid function (TSH [thyroid stimulating hormone], FT4 [free thyroxine], and T3 [triiodothyronine] or FT3 [free triiodothyronine]) and will be sent to the central laboratory for processing. The urine dipstick test will be performed locally at the site. For abnormal CBC results, a manual differential is required. Specifically for AML, if the differential is suggestive of abnormal or immature cells and a possible relapse, a BM biopsy must be performed as part of a scheduled relapse visit. See the laboratory manual for more information. For serum chemistry, calculated creatinine clearance (CrCl) must be assessed during the screening period to determine eligibility. See the laboratory manual for more information. WT1 IHC will be performed locally and is widely available at all surgical pathology laboratories; to further ensure expertise and consistency, sites will be selected based on experience and will have a designated sub-investigator pathologist trained on the interpretation of WT1 staining. For more details on WT1 IHC, please refer to Section 4.1.1., subheading 4 (b).