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Regarding its use in vulnerable populations, such as pregnant or lactating individuals and young children, available data are limited or nonexistent

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The number of evaluable completers was 5 for 0.2 mg SAR425899 and 1 for 0.12 mg SAR425899

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Abbreviations % (v/v): Percent (volume per volume) C: Degree Celsius m: Micrometer a.m.: Ante meridiem CO 2 : Carbon dioxide Cyp11a1 : Cytochrome P450 family 11 subfamily A member 1 Cyp17a1 : Cytochrome P450 family 17 subfamily A member 1 Cyp19a1 :: Cytochrome P450 family 19 subfamily A member 1 ELISA: Enzyme-linked immunosorbent assay GH: Growth hormone GIPP: Gonadotropin-independent precocious puberty GnRH: Gonadotropin-releasing hormone Gnrh1 : Gonadotropin Releasing Hormone 1 HPG axis: Hypothalamus-pituitary-gonad axis hr.: Hour HSD17b: 17-hydroxysteroid dehydrogenase Hsd17b3 : Hydroxysteroid 17 dehydrogenase 3 Hsd3b: 3-hydroxysteroid dehydrogenase Hsd3b1 : Hydroxy-delta-5-steroid dehydrogenase, 3 beta- and steroid delta-isomerase 1 Igf1: Insulin-like growth factor-1 IgG: Immunoglobulin G IU: International units kg: Kilogram Kiss1 : KiSS-1 Metastasis Suppressor L: Liter LCs: Leydig cells LH: Luteinizing hormone Lhb: Luteinizing hormone beta polypeptide Lhcgr : Luteinizing hormone/choriogonadotropin receptor mL: Milliliter mRNA: Messenger RNA PBS: Phosphate buffered saline PCR: Polymerase chain reaction PFA: Paraformaldehyde PLC: Progenitor Leydig cell PND: Postnatal day Prm : Protamine rhGH: Recombinant human growth hormone RNA: Ribonucleic acid Rpl7 : Ribosomal protein L7 rpm: Revolutions per minute RPMI: Roswell Park Memorial Institute medium RT-qPCR: Real-time reverse transcription-polymerase chain reaction Sf1 : Steroidogenic factor 1 Star : Steroidogenic acute regulatory protein T: Testosterone Tnp1 : Transition protein 1 Tnp2 : Transition protein 2 g: Microgram References Navarro VM, Fernandez-Fernandez R, Castellano JM, et al

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